Overweight and ObesityNCT06338709
Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®
A study testing BariClip® Device Treatment in people with Overweight and Obesity, run by Advanced Bariatric Technology.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- BariClip® Device Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Known infection at time of randomization
- Enrolled in another investigational obesity study
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet counts less than 100,000/microliter, or known coagulopathy
- Current substance abuse, alcohol or drug addiction
Show all 17Show fewer
- Chronic pancreatitis or acute pancreatitis within 12 months of randomization
- Diagnosis of autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
- Type I diabetes
- Hiatal hernia > 3cm
- Presence of ulcer in stomach
- 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®
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- BariClip® Device Treatment
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BariClip® Device TreatmentDevice
Device Administration (Implantation)
| Study group | Role | What they receive |
|---|---|---|
| BariClip® Device Treatment | Experimental | Subjects allocated to the Treatment Arm of this study will have a BariClip® device implanted. Receives: Device: BariClip® Device Treatment |
| Control | No intervention | The implantation of a BariClip® device will not be performed on subjects allocated to the Control Arm of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects
Measured: 12 months
Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group
Measured: 12 months
Secondary outcomes (6)
Weight and Height will be combined to report BMI in kg/m^2
Measured: 12 months
Blood Pressure (BP) in mmHg, both systolic and diastolic
Measured: 12 months
Diagnosis and/or Change in Severity of Diabetes Mellitus (DM)
Measured: 12 months
Weight in kilograms
Measured: 12 months
Height in meters
Measured: 12 months
Waist Circumference in centimeters
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 posted1 Apr 2024
- Study startJun 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Bariatric Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Moises Jacobs, MD, Study director, Advanced Bariatric Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338709
- Sponsor's protocol ID
- 11-002
- Status last verified
- Feb 2025
- First submitted
- 18 Mar 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: To assess the safety and effectiveness of the Bariclip in patients with obesity.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®
- ClinicalTrials.gov ID
- NCT06338709
- Acronym / sponsor ID
- 11-002
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Advanced Bariatric TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- Jun 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Apr 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BariClip® Device Treatment | Experimental | Device: BariClip® Device TreatmentSubjects allocated to the Treatment Arm of this study will have a BariClip® device implanted. |
| Control | No intervention | –The implantation of a BariClip® device will not be performed on subjects allocated to the Control Arm of this study. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
- Known infection at time of randomization
- Enrolled in another investigational obesity study
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet counts less than 100,000/microliter, or known coagulopathy
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 |
|---|---|---|
| BariClip® Device TreatmentDevice Administration (Implantation) | Device | BariClip® Device Treatment |
Primary outcome
Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects
Time frame: 12 months
Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group
Time frame: 12 months
6 secondary outcomes
Weight and Height will be combined to report BMI in kg/m^2
Time frame: 12 months
Blood Pressure (BP) in mmHg, both systolic and diastolic
Time frame: 12 months
Diagnosis and/or Change in Severity of Diabetes Mellitus (DM)
Time frame: 12 months
Weight in kilograms
Time frame: 12 months
Height in meters
Time frame: 12 months
Waist Circumference in centimeters
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes. To assess the safety and effectiveness of the Bariclip in patients with obesity.
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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.
Moises Jacobs, MD study director
Advanced Bariatric Technology
Questions about this trial
What is this clinical trial studying?
A study testing BariClip® Device Treatment in people with Overweight and Obesity, run by Advanced Bariatric Technology.
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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Ponce, MD (706-537-7499, jponcemd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects (time frame: 12 months). The study lists 2 primary outcomes in all. 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 5 Feb 2025.