ObesityNCT04362774
ORBERA365 Post-Marketing Clinical Follow-up Study
An observational study of Obesity and Overweight, run by Apollo Endosurgery, Inc. at 1 site in Spain.
Trial summary
A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- ORBERA365
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2021to 10 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese adults who had already consented to receive ORBERA365 and who meet the eligibility criteria for the study.
Who may be able to join
- Male and female adult subjects;
- BMI ≥ 27 kg/m2 and ≤ 50 kg/m2 if treatment is for temporary use for weight loss in subjects who failed to achieve and maintain weight loss with a supervised weight-control program;
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities, if treatment is for pre-surgical temporary use for weight loss in order to reduce surgical risk
- 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 ORBERA365 System Balloon at the same time;
- Prior surgery of the esophagus, stomach, or duodenum;
- 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 upper 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;
- 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 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;
- Alcoholism or drug addiction;
- 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 ORBERA365;
- 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 intragastric balloon therapy, bariatric surgery or considering bariatric surgery during the study;
- 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.
- Known gastrointestinal motility disorders, especially known delayed gastric emptying
- Chronic use of anticholinergic medications and psychotropic medications known to delay gastric emptying.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Open-label, Post-approval Study of the Safety and Effectiveness of ORBERA365 As a 12-month Adjunct to Weight Reduction for Obese Adults or Pre-surgical Weight Reduction for Obese or Super-obese Adults
A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).
Read the detailed description
This is a prospective, multicenter, open label study of the safety and effectiveness of ORBERA365™ for use as an adjunct to behavioral modification for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities). All study subjects will participate in a behavioral modification program for 52 weeks, which will include a low calorie diet as well as nutritional and behavior modification counseling. Subjects will have ORBERA365™ placed for up to 52 weeks.
Evaluations while on treatment will be performed at baseline (pre-placement), Day 0 (ORBERA365 placement) and during monthly clinic visits during the 1st 6 months of device therapy and at months 9 and ORBERA365 removal. All subjects will have a final study visit at 12 months, or study exit, whichever comes first. Device removal will occur at 52 unless removed early by subject request and/or physician recommendation. Reasons for early removal may include, but are not limited to, adverse events, subject dissatisfaction or achievement of weight loss goal.
- Conditions
- Obesity, Overweight
- Being tested
- ORBERA365
- Keywords
- ORBERA
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORBERA365Device
Behavioral modification program in conjunction with endoscopic placement of a single ORBERA365 Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc with 2mL of Methylene blue (10mg/mL)
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Removal Percent
To demonstrate that the percentage of early removals for safety reasons (no including patient requests for removal related to achieving desired weight loss or inability to lose weight and have another procedure) is < 17.5%
Measured: 12 months
Secondary outcomes (6)
Total Body Weight Loss (%TBWL) Responders
To demonstrate >= 50% of completers will achieve >= 10% mean %TBWL at time of device removal. Completer is defined as maintaining device therapy for 12 months or successfully achieving weight loss goal (e.g. at least 5% TBWL) prior to device removal.
Measured: 12 months
Adverse Events (AEs)
To assess the safety of ORBERA365 by summarizing the number of subjects with device- and procedure-related AEs.
Measured: 12 months
% Total Body Weight Loss (%TBWL)
To estimate the %TBWL at 6, 9 and 12 months
Measured: 12 months
% Excess Weight Loss (%EWL)
To estimate the %EWL at 6, 9, and 12 months, assuming an ideal weight based on having a BMI of 25 kg/m2
Measured: 12 months
Body Mass Index (BMI)
To estimate the change from baseline in BMI at 9, 9 and 12 months.
Measured: 12 months
Co-Morbidity Changes
To assess changes in obesity-related co-morbidities at 6, 9, and 12 months, if present at baseline.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start23 Feb 2021
- Primary completion21 Feb 2023
- Study completion10 Oct 2023
Why it stopped: Study was stopped after 1 site completed follow-up of enrolled patients, no other sites were opened in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362774
- Sponsor's protocol ID
- OPTiMA365
- Status last verified
- Dec 2024
- First submitted
- 23 Apr 2020
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only one investigator in this study
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Post-approval Study of the Safety and Effectiveness of ORBERA365 As a 12-month Adjunct to Weight Reduction for Obese Adults or Pre-surgical Weight Reduction for Obese or Super-obese Adults
- ClinicalTrials.gov ID
- NCT04362774
- Acronym / sponsor ID
- OPTiMA365
- Conditions
- Obesity, Overweight
- Keywords
- ORBERA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped after 1 site completed follow-up of enrolled patients, no other sites were opened in the study.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Apollo Endosurgery, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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 ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).
Detailed description
This is a prospective, multicenter, open label study of the safety and effectiveness of ORBERA365™ for use as an adjunct to behavioral modification for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities). All study subjects will participate in a behavioral modification program for 52 weeks, which will include a low calorie diet as well as nutritional and behavior modification counseling. Subjects will have ORBERA365™ placed for up to 52 weeks.
Evaluations while on treatment will be performed at baseline (pre-placement), Day 0 (ORBERA365 placement) and during monthly clinic visits during the 1st 6 months of device therapy and at months 9 and ORBERA365 removal. All subjects will have a final study visit at 12 months, or study exit, whichever comes first. Device removal will occur at 52 unless removed early by subject request and/or physician recommendation. Reasons for early removal may include, but are not limited to, adverse events, subject dissatisfaction or achievement of weight loss goal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese adults who had already consented to receive ORBERA365 and who meet the eligibility criteria for the study.
Key inclusion criteria (6 listed)
- Male and female adult subjects;
- BMI ≥ 27 kg/m2 and ≤ 50 kg/m2 if treatment is for temporary use for weight loss in subjects who failed to achieve and maintain weight loss with a supervised weight-control program;
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities, if treatment is for pre-surgical temporary use for weight loss in order to reduce surgical risk
- 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;
Key exclusion criteria (19 listed)
- Presence of more than one ORBERA365 System Balloon at the same time;
- Prior surgery of the esophagus, stomach, or duodenum;
- 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 upper 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORBERA365Behavioral modification program in conjunction with endoscopic placement of a single ORBERA365 Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc with 2mL of Methylene blue (10mg/mL) | Device | – |
Primary outcome
Early Removal Percent
Time frame: 12 months
To demonstrate that the percentage of early removals for safety reasons (no including patient requests for removal related to achieving desired weight loss or inability to lose weight and have another procedure) is < 17.5%
6 secondary outcomes
Total Body Weight Loss (%TBWL) Responders
Time frame: 12 months
Adverse Events (AEs)
Time frame: 12 months
% Total Body Weight Loss (%TBWL)
Time frame: 12 months
% Excess Weight Loss (%EWL)
Time frame: 12 months
Body Mass Index (BMI)
Time frame: 12 months
Co-Morbidity Changes
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Study was stopped after 1 site completed follow-up of enrolled patients, no other sites were opened in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No. Only one investigator in this study
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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.
1 site 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 1 site in Spain.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was stopped early (reason given: Study was stopped after 1 site completed follow-up of enrolled patients, no other sites were opened in the study.). Results are not available in the source record.
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?
Early Removal Percent (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.