Clinical trial NCT02828657: ORBERA™ Post-Approval Study
Official title: ORBERA™ Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Keywords: ORBERA
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 284
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2

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.

Eligibility criteria: Inclusion Criteria:

1. 22 years of age and older;
2. BMI ≥ 30 kg/m2 and ≤ 40 kg/m2;
3. Have a history of obesity (BMI ≥ 30 kg/m2) for ≥ 2 years;
4. Have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavioral modification programs;
5. 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;
6. Be able to follow the requirements outlined in the protocol, including complying with the visit schedule;
7. Be able to provide written informed consent;

Exclusion Criteria:

1. Presence of more than one intragastric balloon at the same time;
2. Prior gastrointestinal surgery;
3. Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease;
4. 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;
5. Has a large hiatal hernia or hernia \> 5 cm hernia or ≤ 5 cm associated with severe or intractable gastro-esophageal reflux symptoms;
6. 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;
7. Has achalasia or any other severe motility disorder that may pose a safety risk during removal of the device;
8. Has a gastric mass;
9. Has a severe coagulopathy;
10. Has hepatic insufficiency or cirrhosis;
11. 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;
12. 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;
13. Alcoholism or drug addiction;
14. Unable or unwilling to take prescribed proton pump inhibitor medication for the duration of device placement;
15. Unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up;
16. Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants routinely and not under medical supervision;
17. Females who are pregnant, nursing, or planning a pregnancy within the next year;
18. Known to have, or suspected, allergy to materials contained in ORBERA™;
19. Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigational drug or device, or any use of an intragastric balloon prior to this study;
20. Genetically caused obesity;
21. Prior bariatric surgery or considering bariatric surgery during the study ;
22. Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, or weight loss herbal preparations;
23. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study.

Primary outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: 26 weeks
Secondary outcomes:
measure: Percentage of Total Body Weight Loss (%TBWL)
timeFrame: 26 weeks
measure: Adverse Events (AEs)
timeFrame: 12 months
measure: Serious Adverse Events (SAEs)
timeFrame: 12 months
measure: Total Body Weight Loss (%TBWL)
timeFrame: 12 months
measure: Percentage of Excess Weight Loss (%EWL)
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Nutritional Appetite Questionnaire
timeFrame: 12 months
measure: Subject Treatment Satisfaction Survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas, Inc
state: Arkansas
city: San Diego
country: United States
facility: Ellner Bariatric
state: California
city: Saint Petersburg
country: United States
facility: Sun Coast Bariactrics
state: Florida
city: Fairview Heights
country: United States
facility: Metroeast Endoscopic Surgery Center
state: Illinois
city: Louisville
country: United States
facility: Louisville Surgical Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Digestive Health Center / Gastroroenterology Associates
state: Louisiana
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Mount Clemens
country: United States
facility: Allure Medical Spa
state: Michigan
city: Cincinnati
country: United States
facility: Center for Metabolic and Bariatric Surgery
state: Ohio
city: Norman
country: United States
facility: Dr. Keith's Wellness Options
state: Oklahoma
Study officials:
affiliation: Apollo Endosurgery, Inc.
name: Jose L. Naveira
role: STUDY_DIRECTOR
affiliation: Apollo Endosurgery, Inc.
name: James M Buswold
role: STUDY_DIRECTOR
References:
citation: 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.