CompletedNCT06629454Updated Oct 20, 2025Results posted

Digital Incentive Spirometry Adherence

An interventional study of Adherence to digital incentive spirometer in the postop period after major chest surgery. in Pulmonary Function, Incentive Spirometry and Patient Adherence, sponsored by University of Pennsylvania. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 31
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.

Read the detailed description

Incentive spirometry is frequently prescribed as a standard-of-care for patients post-surgery to reduce the risk of developing postoperative pulmonary complications associated with atelectasis. An incentive spirometer (IS) is a mechanical breathing device that assists with pulmonary rehabilitation through improving lung expansion by encouraging deep breathing. While performing incentive spirometry exercises is effective at lowering atelectasis severity, ventilation time, and pulmonary complication rates, patient adherence to performing exercises is very poor. Medical staff, due to time constraints, often cannot supervise all of their patients' entire incentive spirometry regimens (usually every 10-15 min during wakeful hours), contributing to low adherence and incorrect exercise completion. This is compounded by current incentive spirometers lacking a method for accurately collecting patient exercise and adherence data. The present study seeks to evaluate the effect of a digital IS that provides instruction signals and exercise reminders on patients' incentive spirometry adherence.

The objective of this study is to evaluate the effect of a digital IS that provides gentle auditory and haptic reminders and exercise guidance on patient adherence to incentive spirometry. Secondarily, this study will evaluate metrics relating to lung function to assess post-surgery lung recovery in patients using the digital IS.

Conditions studied

Pulmonary Function
Incentive Spirometry
Patient Adherence
Lung Resection
Thoracic Surgery

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Patient Compliance 114

Keywords

Incentive spirometer
Patient adherence
Digital incentive spirometer

In context

Patient Compliance

114 studies on the registry are indexed under Patient Compliance; 38 are open to participants now.

This study's enrollment of 31 is below the median of 120 across 87 interventional studies indexed under Patient Compliance.

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Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, 18 years or older.
Undergoes any anatomic lung resection surgery
An incentive spirometer is expected to be ordered for the patient as standard-of-care
There is no restriction on active medications.

Exclusion criteria

Exclusion Criteria:

There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study:

Vulnerable populations who in the opinion of the investigator are unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
History of prior non-compliance to prescribed therapy or presence or history of significant psychiatric condition (e.g., drug or alcohol addiction, psychosis, schizophrenia), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise.
Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
Single arm proof of concept study of a digital incentive spirometer
This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.
Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.

Interventions

DeviceAdherence to digital incentive spirometer in the postop period after major chest surgery.
Major chest surgery can lead to respiratory compromise and traditional breathing exercises are not supervised or monitored. The primary objective of this study is to evaluate the effect of a multifeatured digital IS and integrated phone app on patient adherence to incentive spirometry. Together the device and app will include the following functions: an auditory and haptic reminder cue, visual and auditory cues to guide exercise completion, exercise gamification, and data tracking and visualization features.

What researchers measure

Primary outcomes

Incentive Spirometry Adherence (Breath Attempts Per Day)
Number of inspiratory breath attempts performed with the digital IS per day.
Time frame: Till discharge or up to 7 days
Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)
Number of hours in which at least one inspiratory breath was attempted using the digital IS per day.
Time frame: Till discharge or up to 7 days

Secondary outcomes

Volume of Inspiratory Breaths Attempted With the Digital IS
Inspiratory volume in milliliters measured from one inhalation from the device
Time frame: Till discharge or up to 7 days
Blood Oxygen Saturation
Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.
Time frame: Till discharge or up to 7 days
Pain Scores
Postoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain). These are then averaged per patient. Mean and range is reported for the entirely of the patient cohort.
Time frame: Till discharge or up to 7 days
Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.
Time frame: Till discharge or up to 7 days

Other outcomes

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Preoperative diffusing capacity of the lung for carbon monoxide to move from air sacs into the bloodstream as a percent of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Forced Expiratory Volume in 1 Second (FEV-1)
Preoperative forced expiration volume in 1 second as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Forced Vital Capacity (FVC)
Preoperative forced vital capacity of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Vital Capacity (VC)
Preoperative vital capacity of the lungs.
Time frame: up to 2 weeks before the surgery
Residual Volume (RV)
Preoperative residual volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Total Lung Capacity (TLC)
Preoperative total lung capacity as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Forced Expiratory Flow (FEF25-75)
Forced expiratory flow rate between 25% and 75% of the forced vital capacity, pre-bronchodilator, as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Thoracic Gas Volume (TGV)
Total gas volume within the chest cavity when the airway is temporarily blocked as a percent of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Expiratory Reserve Volume (ERV)
Expiratory reserve volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Time frame: up to 2 weeks before the surgery
Discharge Survey Responses - Device Engagement
Device engagement survey responses. Patients are instructed on the paper survey to "Circle how much you agree or disagree with the following statements:"
Time frame: On the day of patient discharge from the hospital, an average of 3 days
Discharge Survey Responses - Previous Incentive Spirometry
Have you used an incentive spirometer prior to this hospital stay?
Time frame: On the day of patient discharge from the hospital, an average of 3 days
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
Discharge Survey Question: How much of you exercises do you think you completed?
Time frame: On the day of patient discharge from the hospital, an average of 3 days

Results

Posted Oct 20, 2025

Limitations and caveats

This was a single-arm, open-label study.

Participant flow

31 patients enrolled. 30 patients completed per protocol.

Participant flow — Overall Study
Milestone	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Started	31
Completed	30
Not completed	1
Withdrew: Withdraw by clinician decision	1

Outcome measures

PrimaryIncentive Spirometry Adherence (Breath Attempts Per Day)

Number of inspiratory breath attempts performed with the digital IS per day.

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · Breath attempts

Incentive Spirometry Adherence (Breath Attempts Per Day)
Breath attempts	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Incentive Spirometry Adherence (Breath Attempts Per Day)	45 (23 to 59)

PrimaryIncentive Spirometry Consistency (Hours Per Day With ≥1 Breath)

Number of hours in which at least one inspiratory breath was attempted using the digital IS per day.

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · Hours

Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)
Hours	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)	7.6 (5.75 to 10)

SecondaryVolume of Inspiratory Breaths Attempted With the Digital IS

Inspiratory volume in milliliters measured from one inhalation from the device

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · milliliters

Volume of Inspiratory Breaths Attempted With the Digital IS
milliliters	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Average postoperative volume	1314 (403 to 2517)
Maximum postoperative volume	2375 (716 to 7506)

SecondaryBlood Oxygen Saturation

Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · percentage of oxygen saturation

Blood Oxygen Saturation
percentage of oxygen saturation	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Blood Oxygen Saturation	96 (93 to 98)

SecondaryPain Scores

Postoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain). These are then averaged per patient. Mean and range is reported for the entirely of the patient cohort.

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · units on a scale from 0 to 10

Pain Scores
units on a scale from 0 to 10	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Pain Scores	4 (0 to 7)

SecondaryFlow Rate of Inspiratory Breaths Attempted From the Digital IS

Flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.

Time frame:: Till discharge or up to 7 days
Reported as:: Mean · Milliliters per second

Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Milliliters per second	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Average flow rate	186 (132 to 288)
Maximum flow rate	357 (172 to 405)

Other pre-specifiedDiffusing Capacity of the Lungs for Carbon Monoxide (DLCO)

Preoperative diffusing capacity of the lung for carbon monoxide to move from air sacs into the bloodstream as a percent of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)	79.0 (26.1 to 124)

Other pre-specifiedForced Expiratory Volume in 1 Second (FEV-1)

Preoperative forced expiration volume in 1 second as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Forced Expiratory Volume in 1 Second (FEV-1)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Forced Expiratory Volume in 1 Second (FEV-1)	90.6 (21.5 to 129.3)

Other pre-specifiedForced Vital Capacity (FVC)

Preoperative forced vital capacity of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Forced Vital Capacity (FVC)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Forced Vital Capacity (FVC)	94.4 (66.3 to 135.5)

Other pre-specifiedVital Capacity (VC)

Preoperative vital capacity of the lungs.

Time frame:: up to 2 weeks before the surgery

No measurements were reported for this outcome.

Other pre-specifiedResidual Volume (RV)

Preoperative residual volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Residual Volume (RV)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Residual Volume (RV)	108 (75.3 to 203.6)

Other pre-specifiedTotal Lung Capacity (TLC)

Preoperative total lung capacity as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Total Lung Capacity (TLC)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Total Lung Capacity (TLC)	94.1 (74.3 to 123.0)

Other pre-specifiedForced Expiratory Flow (FEF25-75)

Forced expiratory flow rate between 25% and 75% of the forced vital capacity, pre-bronchodilator, as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Forced Expiratory Flow (FEF25-75)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Forced Expiratory Flow (FEF25-75)	93.9 (8.2 to 189.3)

Other pre-specifiedThoracic Gas Volume (TGV)

Total gas volume within the chest cavity when the airway is temporarily blocked as a percent of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Thoracic Gas Volume (TGV)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Thoracic Gas Volume (TGV)	99.9 (74.7 to 155)

Other pre-specifiedExpiratory Reserve Volume (ERV)

Expiratory reserve volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.

Time frame:: up to 2 weeks before the surgery
Reported as:: Mean · percentage of predicted value

Expiratory Reserve Volume (ERV)
percentage of predicted value	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Expiratory Reserve Volume (ERV)	95.5 (29.8 to 166.9)

Other pre-specifiedDischarge Survey Responses - Device Engagement

Device engagement survey responses. Patients are instructed on the paper survey to "Circle how much you agree or disagree with the following statements:"

Time frame:: On the day of patient discharge from the hospital, an average of 3 days
Reported as:: Count of participants · Participants

Discharge Survey Responses - Device Engagement
Participants	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
It was easy to know when to do my exercises with my device. — Strongly Agree	14
It was easy to know when to do my exercises with my device. — Agree	6
It was easy to know when to do my exercises with my device. — Neutral	1
It was easy to know when to do my exercises with my device. — Disagree	1
It was easy to know when to do my exercises with my device. — Strongly Disagree	0
It was easy to know when to do my exercises with my device. — Incomplete	2
It was easy to know when to do my exercises with my device. — Not applicable	0
I felt motivated to do my exercises. — Strongly Agree	7
I felt motivated to do my exercises. — Agree	10
I felt motivated to do my exercises. — Neutral	5
I felt motivated to do my exercises. — Disagree	0
I felt motivated to do my exercises. — Strongly Disagree	0
I felt motivated to do my exercises. — Incomplete	2
I felt motivated to do my exercises. — Not applicable	0
It was easy to click the button on my device to start an exercise when I wanted to. — Strongly Agree	14
It was easy to click the button on my device to start an exercise when I wanted to. — Agree	10
It was easy to click the button on my device to start an exercise when I wanted to. — Neutral	0
It was easy to click the button on my device to start an exercise when I wanted to. — Disagree	0
It was easy to click the button on my device to start an exercise when I wanted to. — Strongly Disagree	0
It was easy to click the button on my device to start an exercise when I wanted to. — Incomplete	0
It was easy to click the button on my device to start an exercise when I wanted to. — Not applicable	0
I liked how the device gave spoken (audio) instructions for the exercises. — Strongly Agree	9
I liked how the device gave spoken (audio) instructions for the exercises. — Agree	8
I liked how the device gave spoken (audio) instructions for the exercises. — Neutral	3
I liked how the device gave spoken (audio) instructions for the exercises. — Disagree	2
I liked how the device gave spoken (audio) instructions for the exercises. — Strongly Disagree	1
I liked how the device gave spoken (audio) instructions for the exercises. — Incomplete	1
I liked how the device gave spoken (audio) instructions for the exercises. — Not applicable	0
I liked how my nurse/doctor could see my breathing exercise measurements. — Strongly Agree	11
I liked how my nurse/doctor could see my breathing exercise measurements. — Agree	8
I liked how my nurse/doctor could see my breathing exercise measurements. — Neutral	2
I liked how my nurse/doctor could see my breathing exercise measurements. — Disagree	0
I liked how my nurse/doctor could see my breathing exercise measurements. — Strongly Disagree	1
I liked how my nurse/doctor could see my breathing exercise measurements. — Incomplete	2
I liked how my nurse/doctor could see my breathing exercise measurements. — Not applicable	0
I was able to set up the app easily. — Strongly Agree	6
I was able to set up the app easily. — Agree	5
I was able to set up the app easily. — Neutral	0
I was able to set up the app easily. — Disagree	0
I was able to set up the app easily. — Strongly Disagree	0
I was able to set up the app easily. — Incomplete	2
I was able to set up the app easily. — Not applicable	11
I liked the app features. — Strongly Agree	3
I liked the app features. — Agree	6
I liked the app features. — Neutral	3
I liked the app features. — Disagree	0
I liked the app features. — Strongly Disagree	0
I liked the app features. — Incomplete	2
I liked the app features. — Not applicable	10

Other pre-specifiedDischarge Survey Responses - Previous Incentive Spirometry

Have you used an incentive spirometer prior to this hospital stay?

Time frame:: On the day of patient discharge from the hospital, an average of 3 days
Reported as:: Count of participants · Participants

Discharge Survey Responses - Previous Incentive Spirometry
Participants	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
YES	7
NO	12
Incomplete	5

Other pre-specifiedDischarge Survey Responses - Exercise Completion Self-Reported Adherence

Discharge Survey Question: How much of you exercises do you think you completed?

Time frame:: On the day of patient discharge from the hospital, an average of 3 days
Reported as:: Count of participants · Participants

Discharge Survey Responses - Exercise Completion Self-Reported Adherence
Participants	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
0-20%, Close to none	0
21-40%, A few of them	2
41-60%, Around half	7
61-80%, More than half	9
81-100%, Almost all	6
Incomplete	0

Adverse events

Collected over From Enrollment Until 4 Months After Discharge, up to 18 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Arm Proof of Concept Study of a Digital Incentive Spirometer	0/30 (0%)	0/30 (0%)	0/30 (0%)

Baseline characteristics

The baseline analysis includes age, sex, height, weight, race, and ethnicity.

Age, Continuous
Age, Continuous(years)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Mean	66 (33 to 84)

Sex: Female, Male
Sex: Female, Male(Participants)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Female	17
Male	13

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Hispanic or Latino	2
Not Hispanic or Latino	28
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	6
White	22
More than one race	0
Unknown or Not Reported	1

Height
Height(inches)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Mean	66.7 (62 to 74)

Weight
Weight(pounds (lbs))	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Mean	177 (75 to 269)

Procedure Target Lobe
Procedure Target Lobe(Participants)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Right Upper Lobe	10
Right Lower Lobe	8
Left Upper Lobe	5
Left Lower Lobe	3
Right Middle Lobe	1
More than one lobe	3

Preoperative Incentive Spirometry Volume
Preoperative Incentive Spirometry Volume(milliliters)	Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Average preoperative volume	2066 (532 to 3941)
Maximum preoperative volume	2339 (915 to 4204)

1 further baseline measures are reported on the registry.

Study locations

6 sites

Penn Medicine Cherry Hill
Cherry Hill, New Jersey 08003, United States
Penn Medicine Valley Forge
Berwyn, Pennsylvania 19312, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Penn Medicine University City
Philadelphia, Pennsylvania 19104, United States
Penn Thoracic Surgery Presbyterian
Philadelphia, Pennsylvania 19104, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104, United States

References and documents

Study documents

Protocol and statistical analysis plan · Aug 19, 2024
Informed consent form · Nov 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06629454
Lead sponsor: University of Pennsylvania
Responsible party: Sponsor
First posted: Oct 8, 2024
Start date: Dec 27, 2024
Primary completion: Jul 31, 2025
Completion: Jul 31, 2025
Results posted: Oct 20, 2025
Last update: Oct 20, 2025

Study contacts

Doraid Jarrar, MD

principal investigator · University of Pennsylvania

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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