ORBERA™ Post-Approval Study

Obesity Clinical Trial

— OPAS-1  

Official title:

ORBERA™ Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828657
• Other study ID #: OPAS-1
• Status: Completed
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: Apollo Endosurgery, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Digestive Health Center / Gastroroenterology Associates	Baton Rouge	Louisiana
United States	Center for Metabolic and Bariatric Surgery	Cincinnati	Ohio
United States	Metroeast Endoscopic Surgery Center	Fairview Heights	Illinois
United States	Applied Research Center of Arkansas, Inc	Little Rock	Arkansas
United States	Louisville Surgical Associates	Louisville	Kentucky
United States	Surgical Specialists of Louisiana	Metairie	Louisiana
United States	Allure Medical Spa	Mount Clemens	Michigan
United States	Dr. Keith's Wellness Options	Norman	Oklahoma
United States	Sun Coast Bariactrics	Saint Petersburg	Florida
United States	Ellner Bariatric	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Total Body Weight Loss (%TBWL)	To demonstrate that the mean percent Total Body Weight Loss (%TBWL) will be greater than 7.5% at ORBERA™ treatment conclusion (study week 26)	26 weeks
Secondary	Adverse Events (AEs)	To continuously assess the safety of ORBERA™ by summarizing the occurrence of device- and procedure-related Adverse Events (AEs)	12 months
Secondary	Serious Adverse Events (SAEs)	To continuously assess the safety of ORBERA™ by summarizing the occurrence of the following device- or procedure-related SAEs: gastric ulcers, esophageal injury, placement and removal related SAEs, early device removals, and balloon deflations	12 months
Secondary	Total Body Weight Loss (%TBWL)	To estimate the %TBWL at each time point	12 months
Secondary	Percentage of Excess Weight Loss (%EWL)	To estimate the percent Excess Weight Loss (%EWL) at each time point, assuming an ideal weight based on having a BMI of 25 kg/m2	12 months
Secondary	Body Mass Index	To estimate the change from baseline in BMI at each time point	12 months
Secondary	Nutritional Appetite Questionnaire	Will collect data on appetite, feelings of fullness, taste, and eating habits through a patient questionnaire.	12 months
Secondary	Subject Treatment Satisfaction Survey	The Subject Satisfaction Survey will collect data on the subject's level of satisfaction with ORBERA treatment and their recommendation of ORBERA™ treatment to others.	12 months