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NCT06317129 Clinical Trial

Clinical Feasibility Study of the BariTon™ System in Obese Patients

Obesity Clinical Trial

Official title:
Clinical Feasibility Study of the BariTon™ System in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06317129
Other study ID # CP000005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2024
Est. completion date January 31, 2026

Study information
Verified date March 2024
Source BariaTek Medical
Contact Christophe Naz
Phone +33.1.80.20.67.55
Email christophe.naz@bariatek-medical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date January 31, 2026
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted.

Locations
Country Name City State
Uzbekistan Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov Tashkent

Sponsors (1)
Lead Sponsor Collaborator
BariaTek Medical

Country where clinical trial is conducted

Uzbekistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of the BariTon™ Number of patients with device implantation procedure success 3 months
Primary Safety of the BariTon™ Incidence of device related adverse events 3 months
Secondary Safety of the BariTon™ Number of patients with device retrieval procedure success 1 year
Secondary Safety of the BariTon™ Incidence of device related adverse events 1 year
Secondary Efficacy of the BariTon™ Assessment of clinical variables and other metrics 1 year
Secondary Efficacy of the BariTon™ Changes and number of diabetes medication taken 1 year
Secondary Efficacy of the BariTon™ Changes and number of statins medication taken 1 year
Secondary Efficacy of the BariTon™ Changes and number of blood pressure lowering medication taken 1 year
Secondary Efficacy of the BariTon™ Changes in weight related to quality of life (score change of IWQOL-Lite Questionnaire) 1 year
Secondary Efficacy of the BariTon™ Changes in food craving (score change of CoEQ questionnaire) 1 year
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