CClinicalTrials.gg
CompletedNCT04721405Updated Apr 9, 2026

Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest

An observational study in Elective Surgical Procedures, sponsored by Nanowear Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Nanowear Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery

02

Conditions studied

  • Elective Surgical Procedures
03

In context

Lead sponsor

Nanowear Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.

Inclusion criteria

  • Signed informed consent to participate in the study.
  • Female and male subjects, at least 18 years of age at the time of enrolment
  • The patient is scheduled to undergo BodyTite and/or FaceTite procedures.
  • The patients should be willing to comply with the study procedure and schedule.

Exclusion criteria

Exclusion Criteria:

  • Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
  • Pregnancy and nursing.
  • Subject unwilling or unable to comply with wearing the Nanowear System 12 hours daily for at least 48 hours Up to 7 days
  • As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Interventions

  • DeviceObservational Study: No intervention

    Observational Study: No intervention

06

What researchers measure

Primary outcomes

  1. Subject assessment of comfort and compliance

    1\. Subject assessment of comfort and compliance will be filled out by subjects using a 6-points Usability Survey, as follows: * Overall Size of the device - 0 - Being the largest device 5 -Being the smallest. * Secrecy - If patient's are uneasy of people knowing they are wearing a medical device. 0 - Not able to hide 5 - Discrete * Adaptable to size - Can devices be used on all size patients, extreme scales. 0- Not adjustable 5- Can fit all sizes * Device Material - Is the material comfortable to wear. 0 - Uncomfortable 5 - Comfortable * Active Wear - Can patient's wear the device while exercising. 0- Not at all 5 - Can exercise without interference.

    Time frame: 7 days

Secondary outcomes

  1. Investigator assessment of device usability and satisfaction

    2\. Investigator assessment of device usability will be filled out by PI using a 4-points Likert scale, as follows: 3 = Extremely useful in post op care; 2 = Useful in post op care; 1 = Somewhat useful in post op care; 0 = Useless in post op care. 3\. Investigator assessment of satisfaction will be filled out by PI using a 5-points Likert scale, as follows: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Extremely disappointed.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Zucker School of Medicine, Hofstra University
    New York, New York 10019, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04721405
Lead sponsor
Nanowear Inc.
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Sep 14, 2020
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Apr 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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