CompletedNCT02787408SPACERUpdated Oct 25, 2022Results posted

The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

An interventional study of EW Tricuspid Transcatheter Repair System in Tricuspid Valve Regurgitation, sponsored by Edwards Lifesciences. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Read the detailed description

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Conditions studied

Tricuspid Valve Regurgitation

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Tricuspid Valve Insufficiency 225

In context

Tricuspid Valve Insufficiency

225 studies on the registry are indexed under Tricuspid Valve Insufficiency; 108 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 124 interventional studies indexed under Tricuspid Valve Insufficiency.

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Lead sponsor

Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.

Browse Edwards Lifesciences studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
Eighteen years of age or older
Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
Functional tricuspid regurgitation as the primary etiology
New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device
Willing to attend study follow-up assessments for up to 3 years

Exclusion criteria

Exclusion Criteria

Tricuspid valve/right heart anatomy not suitable for the study device:
1. Native tricuspid annulus area \< 2.14 cm2 (9 mm device) or \< 2.63 cm2 (12 mm device) or \< 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
2. Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
3. Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)
Moderate or greater tricuspid valve stenosis
Untreated clinically significant coronary artery disease requiring immediate revascularization
Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
Patients not already receiving dialysis with renal insufficiency (eGFR \<25) per lab test ≤ 48 hours prior to scheduled implant procedure
Myocardial infarction within 30 days of scheduled implant procedure
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
Severe left ventricular dysfunction with ejection fraction \< 25% within 90 days of scheduled implant procedure
Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
Active endocarditis or infection within 3 months of scheduled implant procedure
Cerebrovascular accident within 3 months of scheduled implant procedure
Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
Evidence of right sided intracardiac mass, thrombus, or vegetation
Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
Known hypersensitivity to cobalt chromium, nitinol or titanium
Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
Patient is a current intravenous drug user
Female of child-bearing potential is pregnant or lactating
Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
Patient requires emergent/emergency treatment for tricuspid insufficiency
Patient is under guardianship

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

Experimental
EW Tricuspid Transcatheter Repair System
Edwards (EW) Tricuspid Transcatheter Repair System
Device: EW Tricuspid Transcatheter Repair System

Interventions

DeviceEW Tricuspid Transcatheter Repair System
Treatment with the EW Tricuspid Transcatheter Repair System

What researchers measure

Primary outcomes

All-cause Mortality
The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.
Time frame: At 30 days.

Secondary outcomes

Technical Success
Alive, with * Successful access, delivery and removal of the delivery systems, and * Deployment and correct positioning of the intended device, and * No need for additional emergency surgery or re-intervention related to the device or access procedure
Time frame: Implant Procedure
Device Success
Alive, with * Original intended device in place, and * No additional surgical or interventional procedures related to the device, and * Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg
Time frame: At 1 month, 6 months, 1, 2, and 3 years
Procedural Success
Device Success, and None of the following device or procedure related Serious Adverse Events (SAE): * Life threatening bleeding * Major vascular or cardiac structural complications requiring intervention * Pericardial effusion requiring drainage or surgery (includes tamponade) * Stage 2 or 3 acute kidney injury (includes new dialysis). * Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support * Prolonged intubation \> 48 hours
Time frame: At 1 month
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
Re-hospitalization rates for the underlying condition (heart failure)
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
Re-intervention rates for the underlying condition (tricuspid regurgitation)
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Changes in Peripheral Edema]
Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Change in 6 minute walk test distance (meters) compared to baseline
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.
Time frame: At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time frame: At 1 month, 6 months, 1, 2 and 3 years

Results

Posted Oct 25, 2022

Participant flow

Participant flow — Overall Study
Milestone	EW Tricuspid Transcatheter Repair System
Started	25
Completed	7
Not completed	18
Withdrew: Death	16
Withdrew: Withdrawal by subject	1
Withdrew: Non-implanted patient exited post 6 month follow-up visit per protocol	1

Outcome measures

PrimaryAll-cause Mortality

The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.

Time frame:: At 30 days.
Reported as:: Count of participants · Participants

All-cause Mortality
Participants	EW Tricuspid Transcatheter Repair System
All-cause Mortality	2

SecondaryTechnical Success

Alive, with * Successful access, delivery and removal of the delivery systems, and * Deployment and correct positioning of the intended device, and * No need for additional emergency surgery or re-intervention related to the device or access procedure

Time frame:: Implant Procedure
Reported as:: Count of participants · Participants

Technical Success
Participants	EW Tricuspid Transcatheter Repair System
Technical Success	22

SecondaryDevice Success

Alive, with * Original intended device in place, and * No additional surgical or interventional procedures related to the device, and * Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg

Time frame:: At 1 month, 6 months, 1, 2, and 3 years
Reported as:: Count of participants · Participants

Device Success
Participants	EW Tricuspid Transcatheter Repair System
30 days	4
6 months	3
1 year	3
2 years	2
3 years	0

SecondaryProcedural Success

Device Success, and None of the following device or procedure related Serious Adverse Events (SAE): * Life threatening bleeding * Major vascular or cardiac structural complications requiring intervention * Pericardial effusion requiring drainage or surgery (includes tamponade) * Stage 2 or 3 acute kidney injury (includes new dialysis). * Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support * Prolonged intubation \> 48 hours

Time frame:: At 1 month
Reported as:: Count of participants · Participants

Procedural Success
Participants	EW Tricuspid Transcatheter Repair System
Procedural Success	4

SecondaryClinical Outcomes [Heart Failure Re-Hospitalization Rates]

Re-hospitalization rates for the underlying condition (heart failure)

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Number · Percentage of participants

Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
Percentage of participants	EW Tricuspid Transcatheter Repair System
KM Estimate at 30 days	100.0 (100.0 to 100.0)
KM Estimate at 6 months	91.3 (69.5 to 97.8)
KM Estimate at 1 year	85.6 (61.2 to 95.2)
KM Estimate at 2 years	72.9 (45.7 to 88.0)
KM Estimate at 3 years	72.9 (45.7 to 88.0)

SecondaryClinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]

Re-intervention rates for the underlying condition (tricuspid regurgitation)

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Number · Percentage of participants

Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
Percentage of participants	EW Tricuspid Transcatheter Repair System
KM Estimate at 30 days	96.0 (74.8 to 99.4)
KM Estimate at 6 months	96.0 (74.8 to 99.4)
KM Estimate at 1 year	96.0 (74.8 to 99.4)
KM Estimate at 2 years	96.0 (74.8 to 99.4)
KM Estimate at 3 years	96.0 (74.8 to 99.4)

SecondaryClinical Outcomes [Changes in Peripheral Edema]

Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Mean · kg

Clinical Outcomes [Changes in Peripheral Edema]
kg	EW Tricuspid Transcatheter Repair System
Baseline 1 month	75.1 ± 14.94
1 month	73.1 ± 13.34
Baseline 6 months	72.7 ± 13.25
6 months	70.2 ± 11.99
Baseline 1 year	74.3 ± 13.17
1 year	71.0 ± 10.87
Baseline 2 years	76.5 ± 13.13
2 years	71.9 ± 8.80
Baseline 3 years	81.3 ± 13.93
3 years	71.8 ± 11.56

SecondaryClinical Outcomes [Change in New York Heart Association (NYHA) Class]

Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Count of participants · Participants

Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Participants	EW Tricuspid Transcatheter Repair System
Baseline — Class I	0
Baseline — Class II	5
Baseline — Class III	12
Baseline — Class IV	5
30 Days — Class I	2
30 Days — Class II	12
30 Days — Class III	8
30 Days — Class IV	0
6 months — Class I	6
6 months — Class II	8
6 months — Class III	4
6 months — Class IV	1
1 year — Class I	5
1 year — Class II	7
1 year — Class III	5
1 year — Class IV	0
2 years — Class I	5
2 years — Class II	5
2 years — Class III	0
2 years — Class IV	1
3 years — Class I	3
3 years — Class II	0
3 years — Class III	1
3 years — Class IV	0

SecondaryClinical Outcomes [Change in 6 Minute Walk Test Distance]

Change in 6 minute walk test distance (meters) compared to baseline

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Mean · Meters

Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Meters	EW Tricuspid Transcatheter Repair System
Baseline 1 Month	328.7 ± 83.88
1 month	333.2 ± 107.90
Baseline 6 months	329.9 ± 72.49
6 months	351.6 ± 77.04
Baseline 1 year	320.9 ± 76.94
1 year	353.0 ± 110.93
Baseline 2 years	322.0 ± 92.17
2 years	262.0 ± 115.85
Baseline 3 years	339.0 ± 0
3 years	180.0 ± 0

SecondaryClinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]

Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Mean · score on a scale

Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
score on a scale	EW Tricuspid Transcatheter Repair System
Baseline 1 month	36.3 ± 11.14
1 month	39.4 ± 9.25
Baseline 6 months	37.7 ± 11.24
6 months	40.3 ± 9.75
Baseline 1 year	35.6 ± 11.03
1 year	42.7 ± 12.08
Baseline 2 years	41.0 ± 10.32
2 years	44.3 ± 10.06
Baseline 3 years	40.8 ± 11.38
3 years	43.4 ± 7.41

SecondaryClinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]

Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.

Time frame:: At 1 month, 6 months, 1, 2 and 3 years
Reported as:: Mean · score on a scale

Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
score on a scale	EW Tricuspid Transcatheter Repair System
Baseline 1 month	48.7 ± 31.23
1 month	59.6 ± 27.68
Baseline 6 months	49.7 ± 33.11
6 months	71.9 ± 28.19
Baseline 1 year	46.2 ± 34.48
1 year	70.8 ± 26.25
Baseline 2 years	60.9 ± 34.12
2 years	76.0 ± 25.48
Baseline 3 years	56.4 ± 38.97
3 years	75.9 ± 22.08

Adverse events

Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
EW Tricuspid Transcatheter Repair System	16/25 (64%)	20/25 (80%)	23/25 (92%)

Most frequent serious events

Showing 10 of 48

Most frequent serious events
Event	EW Tricuspid Transcatheter Repair System
Cardiac failureCardiac disorders	9/25
Cardiac arrestCardiac disorders	4/25
Cardiogenic shockCardiac disorders	3/25
SepsisInfections and infestations	3/25
Procedural haemorrhageInjury, poisoning and procedural complications	3/25
Renal failureRenal and urinary disorders	3/25
Cerebrovascular accidentNervous system disorders	3/25
Acute myocardial infarctionCardiac disorders	2/25
Ventricular tachycardiaCardiac disorders	2/25
EndocarditisInfections and infestations	2/25

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	EW Tricuspid Transcatheter Repair System
Cardiac failureCardiac disorders	12/25
Renal failureRenal and urinary disorders	7/25
Cardiac arrestCardiac disorders	4/25
Cerebrovascular accidentNervous system disorders	4/25
Cardiogenic shockCardiac disorders	3/25
Procedural haemorrhageInjury, poisoning and procedural complications	3/25
Acute kidney injuryRenal and urinary disorders	3/25
SepsisInfections and infestations	3/25
Acute myocardial infarctionCardiac disorders	2/25
BradycardiaCardiac disorders	2/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)	EW Tricuspid Transcatheter Repair System
Mean	74.6 ± 7.06

Sex: Female, Male
Sex: Female, Male(Participants)	EW Tricuspid Transcatheter Repair System
Female	11
Male	14

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	EW Tricuspid Transcatheter Repair System

Region of Enrollment
Region of Enrollment(Participants)	EW Tricuspid Transcatheter Repair System
Greece	4
Canada	11
France	1
Switzerland	1
Germany	8

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	EW Tricuspid Transcatheter Repair System
Mean	26.2 ± 4.74

New York Heart Association Class (NYHA)
New York Heart Association Class (NYHA)(Participants)	EW Tricuspid Transcatheter Repair System
Class I	0
Class II	6
Class III	14
Class IV	5

The European System for Cardiac Operative Risk Evaluation: EuroScore II
The European System for Cardiac Operative Risk Evaluation: EuroScore II(Percentage of surgical risk)	EW Tricuspid Transcatheter Repair System
Mean	11.5 ± 7.65

History of Heart Failure
History of Heart Failure(Participants)	EW Tricuspid Transcatheter Repair System
Count of participants	13

19 further baseline measures are reported on the registry.

Study locations

11 sites

St. Paul's Hospital, Providence Health Care Research Institute
Vancouver, British Columbia V6E 1M7, Canada
Toronto General Hospital
Toronto, Ontario M5G 2C4, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval
Québec, G1V 4G5, Canada
Institut Hospitalier Jacques Cartier
Massy, 91300, France
Hōpital Charles Nicolle
Rouen, 76031, France
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189, Germany
Charite-Universitätsmedzin Berlin
Berlin, 10117, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Munich University Clinic, Ludwig-Maximilian University
Munich, 81377, Germany
Hygeia Hospital
Athens, 15123, Greece
Inselspital, Universitätsspital Bern
Bern, 3010, Switzerland

References and documents

Study documents

Study protocol · Oct 10, 2016
Study protocol · Dec 16, 2016
Statistical analysis plan · Jun 12, 2017

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

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Jan 2018, 16 months.

Results were first posted in Oct 2022, 4 years 8 months after primary completion.

Of 54 industry-sponsored interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 70. This study's 16 months is below that.

Counting every sponsor, half of 83 studies reached it within 38 months; a quarter within 22 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 11, 2016
First posted: Jun 1, 2016
StartActual: Sep 14, 2016
Primary completionActual: Jan 30, 2018
CompletionActual: Dec 14, 2020
Results first posted: Oct 25, 2022
Last update: Oct 25, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02787408
Lead sponsor: Edwards Lifesciences
Responsible party: Sponsor
First posted: Jun 1, 2016
Start date: Sep 14, 2016
Primary completion: Jan 30, 2018
Completion: Dec 14, 2020
Results posted: Oct 25, 2022
Last update: Oct 25, 2022

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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