Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT02828657
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ORBERA™ Post-Approval Study
Sponsor:
Apollo Endosurgery, Inc.
Organization:
Study Overview
Official Title:
ORBERA™ Post-Approval Study
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAS-1
Brief 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
Detailed Description:
FDA post-approval study designed to demonstrate 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. Behavioral modification program in conjunction with endoscopic placement of a single ORBERA™ Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc, for 26 weeks followed by endoscopic ORBERA™ removal. Outcomes include the mean percent Total Body Weight Loss (%TBWL), changes in weight, device and procedure-related AEs and SAEs: gastric ulcers, esophageal injury, placement and removal related SAEs, early device removals, and balloon deflations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: