Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.
Not Applicable
Recruiting
- Conditions
- Obesity
- Interventions
- Device: Endoscopic gastric restriction and biliodigestive diversion
- Registration Number
- NCT06360679
- Lead Sponsor
- BariaTek Medical
- Brief Summary
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Male and female subjects aged between 25 and 60 years inclusive
- 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
- Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to enrolment
- Willing and able to provide written informed consent
- 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 Score changes in food craving using CoEQ Questionnaire
Trial Locations
- Locations (2)
BMI Clinic Double Bay
🇦🇺Sydney, New South Wales, Australia
BMI Clinic Liverpool
🇦🇺Sydney, New South Wales, Australia