ORBERA™ Post-Approval Study
OPAS-1
1 other identifier
observational
284
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 13, 2020
July 1, 2020
3.5 years
June 28, 2016
July 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serious Adverse Events (SAEs)
Incidence of device and procedure-related Serious Adverse Events (SAEs) after 26 weeks of ORBERA™ treatment will be no greater than 15%
26 weeks
Secondary Outcomes (8)
Percentage of Total Body Weight Loss (%TBWL)
26 weeks
Adverse Events (AEs)
12 months
Serious Adverse Events (SAEs)
12 months
Total Body Weight Loss (%TBWL)
12 months
Percentage of Excess Weight Loss (%EWL)
12 months
- +3 more secondary outcomes
Eligibility Criteria
Obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2
You may qualify if:
- years of age and older;
- BMI ≥ 30 kg/m2 and ≤ 40 kg/m2;
- Have a history of obesity (BMI ≥ 30 kg/m2) for ≥ 2 years;
- Have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavioral modification programs;
- Be willing to commit to a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance;
- Be able to follow the requirements outlined in the protocol, including complying with the visit schedule;
- Be able to provide written informed consent;
You may not qualify if:
- Presence of more than one intragastric balloon at the same time;
- Prior gastrointestinal surgery;
- Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease;
- Has any gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the GI tract such as atresias or stenosis;
- Has a large hiatal hernia or hernia \> 5 cm hernia or ≤ 5 cm associated with severe or intractable gastro-esophageal reflux symptoms;
- Has a structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope;
- Has achalasia or any other severe motility disorder that may pose a safety risk during removal of the device;
- Has a gastric mass;
- Has a severe coagulopathy;
- Has hepatic insufficiency or cirrhosis;
- Has any other medical condition which would not permit elective endoscopy, such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease;
- Has serious or uncontrolled psychiatric illness or disorder that could compromise subject understanding of or compliance with follow-up visits and removal of the device after 6 months;
- Alcoholism or drug addiction;
- Unable or unwilling to take prescribed proton pump inhibitor medication for the duration of device placement;
- Unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, 72212, United States
Ellner Bariatric
San Diego, California, 92120, United States
Sun Coast Bariactrics
St. Petersburg, Florida, 33716, United States
Metroeast Endoscopic Surgery Center
Fairview Heights, Illinois, United States
Louisville Surgical Associates
Louisville, Kentucky, 40215, United States
Digestive Health Center / Gastroroenterology Associates
Baton Rouge, Louisiana, 70809, United States
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Allure Medical Spa
Mount Clemens, Michigan, 48043, United States
Center for Metabolic and Bariatric Surgery
Cincinnati, Ohio, 45241, United States
Dr. Keith's Wellness Options
Norman, Oklahoma, 73069, United States
Related Publications (1)
Moore RL, Eaton L, Ellner J. Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. Obes Surg. 2020 Nov;30(11):4267-4274. doi: 10.1007/s11695-020-04798-5.
PMID: 32617919DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose L. Naveira
Apollo Endosurgery, Inc.
- STUDY DIRECTOR
James M Buswold
Apollo Endosurgery, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
July 11, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 13, 2020
Record last verified: 2020-07