Clinical Feasibility Study of the BariTon™ System in Obese Patients

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Device: Endoscopic gastric restriction and biliodigestive diversion

• Registration Number: NCT06317129
• Lead Sponsor: BariaTek Medical

Brief Summary

Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-18
• Study First Submitted: 2024-01-18
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-10-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Male and female subjects aged between 25 and 60 years inclusive
2. A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
3. Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to enrolment
4. Willing and able to provide written informed consent
5. Willing and able to comply with the study procedures and follow-up schedule

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BariTon™ System implantation	Endoscopic gastric restriction and biliodigestive diversion	-

Primary Outcome Measures

Name	Time	Method
Safety of the BariTon™	3 months	Incidence of device related adverse events

Secondary Outcome Measures

Name	Time	Method
Safety of the BariTon™	1 year	Incidence of device related adverse events
Efficacy of the BariTon™	1 year	Changes in food craving (score change of CoEQ questionnaire)

Trial Locations

Locations (1)

Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov; 🇺🇿 Tashkent, Uzbekistan