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Not yet recruitingNCT06338709Updated Feb 5, 2025

Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®

An interventional study of BariClip® Device Treatment in Overweight and Obesity, sponsored by Advanced Bariatric Technology. Not yet recruiting. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Advanced Bariatric Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
22 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Overweight and Obesity
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 165 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

This is the only study on the registry with Advanced Bariatric Technology as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    BariClip® Device Treatment

    Subjects allocated to the Treatment Arm of this study will have a BariClip® device implanted.

    Device: BariClip® Device Treatment

  • No intervention
    Control

    The implantation of a BariClip® device will not be performed on subjects allocated to the Control Arm of this study.

Interventions

  • DeviceBariClip® Device Treatment

    Device Administration (Implantation)

06

What researchers measure

Primary outcomes

  1. Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects

    Time frame: 12 months

  2. Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group

    Time frame: 12 months

Secondary outcomes

  1. Weight and Height will be combined to report BMI in kg/m^2

    Time frame: 12 months

  2. Blood Pressure (BP) in mmHg, both systolic and diastolic

    Time frame: 12 months

  3. Diagnosis and/or Change in Severity of Diabetes Mellitus (DM)

    Time frame: 12 months

  4. Weight in kilograms

    Time frame: 12 months

  5. Height in meters

    Time frame: 12 months

  6. Waist Circumference in centimeters

    Time frame: 12 months

Other outcomes

  1. Incidence of Serious Adverse Events (SAEs)

    Time frame: Through study completion, total study duration estimated to be 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — To assess the safety and effectiveness of the Bariclip in patients with obesity.

Supporting information: Study protocol, Clinical study report

Time frame: Data available 1 year after last enrolled patient

Access criteria: Access only to blinded study monitor until FDA approval of PMA

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Aug 2025, 2 months later.

Of 116 industry-sponsored interventional studies with no phase under Overweight, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 2 months is below that.

Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2024
First posted
Apr 1, 2024
StartEst.
Jun 2025
Primary completionEst.
Aug 2025
CompletionEst.
Aug 2026
Last update
Feb 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06338709
Lead sponsor
Advanced Bariatric Technology
Collaborators
NAMSA
Responsible party
Sponsor
First posted
Apr 1, 2024
Start date
Jun 2025 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Aug 2026 (estimated)
Last update
Feb 5, 2025

Study contacts

Jaime Ponce, MD
Contact
jponcemd@gmail.com
706-537-7499
Herbert Lerner, MD
Contact
herb.lerner@gmail.com
301-520-2115
Moises Jacobs, MD
study director · Advanced Bariatric Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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