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

NCT06338709 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 11-002
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

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

  12 months

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

  12 months

Secondary Outcomes (6)

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

  12 months

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

  12 months

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

  12 months

• Weight in kilograms

  12 months

• Height in meters

  12 months

Other Outcomes (1)

• Incidence of Serious Adverse Events (SAEs)

  Through study completion, total study duration estimated to be 24 months

Study Arms (2)

BariClip® Device Treatment

EXPERIMENTAL

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

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.

Interventions

BariClip® Device Treatment DEVICE

Device Administration (Implantation)

BariClip® Device Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Bariatric Technology: lead
• NAMSA: collaborator

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moises Jacobs, MD

  Advanced Bariatric Technology

  STUDY DIRECTOR

Central Study Contacts

Jaime Ponce, MD

CONTACT

706-537-7499; jponcemd@gmail.com

Herbert Lerner, MD

CONTACT

301-520-2115; herb.lerner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 1, 2024
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data available 1 year after last enrolled patient
• Access Criteria: Access only to blinded study monitor until FDA approval of PMA