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NCT05086302 · ClinicalTrials.gov registry record
Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study
A clinical trial of Obesity, sponsored by Spatz FGIA.
- Completed
- Registry status
- 537
- Enrollment target
- 20
- Study locations
NCT05086302: Completed study of Obesity, sponsored by Spatz FGIA.
NCT05086302 is a study of Obesity that has completed, run by Spatz FGIA. The registered enrollment target is 537 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086302, a study of Obesity, has completed, sponsored by Spatz FGIA.
- COMPLETED
- Registry status
- 537 participants
- Enrollment target
- 20
- Study locations
Study Summary
A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.
Primary Outcome
The primary study endpoint is to demonstrate that the rate of device or procedure related SAEs is less than 8% at 8 months
Conditions Studied
Study Locations (20)
New Jersey
- Reveal Weight Loss - Livingston
- Weight Loss and Wellness Center - Livingston
- New Jersey Bariatric Center - Springfield
- New York Bariatric Group - Wayne Location - Wayne
Florida
- JSAPA - Jupiter
- Formation - Tampa
Maryland
- Gastro Center of Maryland - Columbia
- The Silhouette Clinic - Germantown
North Carolina
- True You Weight Loss - Cary
- Atlantic Medical Group - Kinston
Virginia
- Endoscopic Wellness Center of America - Reston
- Advanced Gastroenterology & Hepatology of Greater Washington - Vienna
California
- Carson D Liu MD Medical Corp - Marina del Rey
Georgia
- True You Weight Loss (Atlanta) - Atlanta
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2025-01-13 |
What the finished NCT05086302 record still lists
NCT05086302 is an observational study that tracks outcomes without assigning an intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT05086302 names 20 study sites across 13 states, led by New Jersey, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05086302 about?
NCT05086302 is a clinical study titled "Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study". A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program....
What is the current status of trial NCT05086302?
This trial is currently completed. The enrollment target is 537 participants. The study started on 2021-12-03. Estimated completion is 2025-01-13.
What conditions does trial NCT05086302 study?
This clinical trial studies the following conditions: Obesity.
Who is sponsoring clinical trial NCT05086302?
This trial is sponsored by Spatz FGIA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05086302 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05086302's enrollment target sits among peer trials
537 128th of 1053 higher than 926 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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