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NCT02828657 · ClinicalTrials.gov registry record
ORBERA™ Post-Approval Study
A clinical trial, sponsored by Apollo Endosurgery.
- Completed
- Registry status
- 284
- Enrollment target
NCT02828657: Completed study, sponsored by Apollo Endosurgery.
NCT02828657 is a clinical trial that has completed, run by Apollo Endosurgery. The registered enrollment target is 284 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02828657 has completed, sponsored by Apollo Endosurgery.
- COMPLETED
- Registry status
- 284 participants
- Enrollment target
Study Summary
A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2
Primary Outcome
Incidence of device and procedure-related Serious Adverse Events (SAEs) after 26 weeks of ORBERA™ treatment will be no greater than 15%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-12 |
What the finished NCT02828657 record still lists
NCT02828657 is an observational study that tracks outcomes without assigning an intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02828657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02828657 about?
NCT02828657 is a clinical study titled "ORBERA™ Post-Approval Study". A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2
What is the current status of trial NCT02828657?
This trial is currently completed. The enrollment target is 284 participants. The study started on 2016-06. Estimated completion is 2019-12.
Who is sponsoring clinical trial NCT02828657?
This trial is sponsored by Apollo Endosurgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
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