Clinical Feasibility Study of the BariTon™ System in Obese Patients

BariaTek Medical

Status: Enrolling

Conditions: Obesity

Treatments: Device: Endoscopic gastric restriction and biliodigestive diversion

Study type: Interventional

Funder types: Industry

Identifiers

NCT06317129

CP000005

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

BariTon™ System implantation

Experimental group

Treatment:

Device: Endoscopic gastric restriction and biliodigestive diversion