ORBERA™ Post-Approval Study (OPAS-1)

July 9, 2020 updated by: Apollo Endosurgery, Inc.
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas, Inc
    • California
      • San Diego, California, United States, 92120
        • Ellner Bariatric
    • Florida
      • Saint Petersburg, Florida, United States, 33716
        • Sun Coast Bariactrics
    • Illinois
      • Fairview Heights, Illinois, United States
        • Metroeast Endoscopic Surgery Center
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Louisville Surgical Associates
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Digestive Health Center / Gastroroenterology Associates
      • Metairie, Louisiana, United States, 70001
        • Surgical Specialists of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
    • Michigan
      • Mount Clemens, Michigan, United States, 48043
        • Allure Medical Spa
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Center for Metabolic and Bariatric Surgery
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Dr. Keith's Wellness Options

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs)
Time Frame: 26 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Total Body Weight Loss (%TBWL)
Time Frame: 26 weeks
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
Adverse Events (AEs)
Time Frame: 12 months
To continuously assess the safety of ORBERA™ by summarizing the occurrence of device- and procedure-related Adverse Events (AEs)
12 months
Serious Adverse Events (SAEs)
Time Frame: 12 months
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
Total Body Weight Loss (%TBWL)
Time Frame: 12 months
To estimate the %TBWL at each time point
12 months
Percentage of Excess Weight Loss (%EWL)
Time Frame: 12 months
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
Body Mass Index
Time Frame: 12 months
To estimate the change from baseline in BMI at each time point
12 months
Nutritional Appetite Questionnaire
Time Frame: 12 months
Will collect data on appetite, feelings of fullness, taste, and eating habits through a patient questionnaire.
12 months
Subject Treatment Satisfaction Survey
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Apollo Endosurgery, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jose L. Naveira, Apollo Endosurgery, Inc.
  • Study Director: James M Buswold, Apollo Endosurgery, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPAS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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