ObesityOPAS-1NCT02828657
ORBERA™ Post-Approval Study
An observational study of Obesity and Overweight, run by Apollo Endosurgery, Inc. at 11 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obesity, Overweight
- How many people
- 284 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 22 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;
Who cannot join
- 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;
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- 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;
- Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants routinely and not under medical supervision;
- Females who are pregnant, nursing, or planning a pregnancy within the next year;
- Known to have, or suspected, allergy to materials contained in ORBERA™;
- 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;
- Genetically caused obesity;
- Prior bariatric surgery or considering bariatric surgery during the study ;
- Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, or weight loss herbal preparations;
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Digestive Health Center / Gastroroenterology Associates
Baton Rouge, Louisiana, 70809
Center for Metabolic and Bariatric Surgery
Cincinnati, Ohio, 45241
Metroeast Endoscopic Surgery Center
Fairview Heights, Illinois
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, 72212
Louisville Surgical Associates
Louisville, Kentucky, 40215
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
Allure Medical Spa
Mount Clemens, Michigan, 48043
Dr. Keith's Wellness Options
Norman, Oklahoma, 73069
Ellner Bariatric
San Diego, California, 92120
Sun Coast Bariactrics
St. Petersburg, Florida, 33716
About this study
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
Read the 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.
- Conditions
- Obesity, Overweight
- Keywords
- ORBERA
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 26 weeks
Secondary outcomes (8)
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)
Measured: 26 weeks
Adverse Events (AEs)
To continuously assess the safety of ORBERA™ by summarizing the occurrence of device- and procedure-related Adverse Events (AEs)
Measured: 12 months
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
Measured: 12 months
Total Body Weight Loss (%TBWL)
To estimate the %TBWL at each time point
Measured: 12 months
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
Measured: 12 months
Body Mass Index
To estimate the change from baseline in BMI at each time point
Measured: 12 months
Nutritional Appetite Questionnaire
Will collect data on appetite, feelings of fullness, taste, and eating habits through a patient questionnaire.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Endosurgery, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose L. Naveira, Study director, Apollo Endosurgery, Inc.James M Buswold, Study director, Apollo Endosurgery, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828657
- Sponsor's protocol ID
- OPAS-1
- Acronym
- OPAS-1
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32617919
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORBERA™ Post-Approval Study
- ClinicalTrials.gov ID
- NCT02828657
- Acronym / sponsor ID
- OPAS-1 / OPAS-1
- Conditions
- Obesity, Overweight
- Keywords
- ORBERA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 22 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
8 secondary outcomes
Percentage of Total Body Weight Loss (%TBWL)
Time frame: 26 weeks
Adverse Events (AEs)
Time frame: 12 months
Serious Adverse Events (SAEs)
Time frame: 12 months
Total Body Weight Loss (%TBWL)
Time frame: 12 months
Percentage of Excess Weight Loss (%EWL)
Time frame: 12 months
Body Mass Index
Time frame: 12 months
Nutritional Appetite Questionnaire
Time frame: 12 months
Subject Treatment Satisfaction Survey
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Derived from this study: PubMed 32617919Moore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L. Naveira study director
Apollo Endosurgery, Inc.
James M Buswold study director
Apollo Endosurgery, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Apollo Endosurgery, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (SAEs) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.