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

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 Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Device: BariClip® Device Treatment

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herbert Lerner, MD; Phone Number: 301-520-2115; Email: herb.lerner@gmail.com
• Study Contact Backup: Name: Jaime Ponce, MD; Phone Number: 706-537-7499; Email: jponcemd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BariClip® Device Treatment; Subjects allocated to the Treatment Arm of this study will have a BariClip® device implanted.	Device: BariClip® Device Treatment; Device Administration (Implantation)
No Intervention: Control; The implantation of a BariClip® device will not be performed on subjects allocated to the Control Arm of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Waist Circumference in centimeters	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Serious Adverse Events (SAEs)	Through study completion, total study duration estimated to be 24 months

Collaborators and Investigators

• Sponsor: Advanced Bariatric Technology
• Collaborators: NAMSA
• Investigators: Study Director: Moises Jacobs, MD, Advanced Bariatric Technology

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 11-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To assess the safety and effectiveness of the Bariclip in patients with obesity.
• IPD Sharing Time Frame: Data available 1 year after last enrolled patient
• IPD Sharing Access Criteria: Access only to blinded study monitor until FDA approval of PMA
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes