NCT06338709Not yet recruiting
Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Advanced Bariatric Technology
- Diseases
- Obesity
- NCT number
- NCT06338709
What you commit to
- Study type: Interventional
- Planned participants: 165
- From 1 Jun 2025 to the primary completion date, 31 Aug 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of any device for the treatment of obesity
- Known hepatic disease or biliary disease prior to screening (e.g., viral, autoimmune, fibrosis /cirrhosis etiology, but not including incidental fatty liver)
- Current substance abuse, alcohol or drug addiction
- Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected need to use during the first 12 months after the index procedure
- Taking prescription antithrombotic therapy (e.g., anticoagulant, or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the first 12 months after the index procedure
- Taking any of the medications on the list of Excluded Medications within 30 days prior to randomization and/or there is a need or expected need to use these medications during the first 12 months after the enrollment
Other illness
- Known infection at time of randomization
- Diagnosis of autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
- Type I diabetes
- Presence of ulcer in stomach
Lab values
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet counts less than 100,000/microliter, or known coagulopathy
Other
- Enrolled in another investigational obesity study
- Chronic pancreatitis or acute pancreatitis within 12 months of randomization
- Hiatal hernia \> 3cm
- Severe esophagitis (LA classification grade C or D)
- Presence of Barrett's esophagus
- Presence of any other abnormality that impacts the placement of the BariClip®
Who the study is looking for
- Age ≥22 years and ≤65 years
- Have signed an Informed Consent Form
- BMI 30-34.9 (with comorbidity) and 35-45 (with or without comorbidity) kg/m2
- Willing to comply with study requirements
- Subjects of childbearing potential not intending to become pregnant for the duration of their trial participation, with a documented negative pregnancy test and documentation of contraception confirmation and method
- History of obesity and being overweight (BMI \>30kg/m2) for at least 1 year
- History of failure of non-surgical weight loss methods
- Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study
Age in the registry: 22 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.