Evaluation of the BariTon™ System for treating obesity
Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
This study is testing a new device called BariTon™ to see if it can help people aged 25 to 60 who are struggling with obesity lose weight and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | BariaTek Medical Industry-sponsored |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT06360679 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and effectiveness of the BariTon™ device, which is designed for endoscopic gastric restriction and biliodigestive diversion in obese or overweight patients. Participants will be individuals aged 25 to 60 with a BMI between 30 and 40 who have struggled with obesity for at least two years. The study aims to evaluate how well this device can help patients achieve weight loss and improve their health outcomes. Participants will be monitored for their compliance with study procedures and follow-up schedules.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 60 with a BMI between 30 and 40 who have a history of obesity and have failed previous weight loss attempts.
Not a fit: Patients outside the age range of 25 to 60 or with a BMI below 30 or above 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new effective option for weight loss in obese patients who have not succeeded with traditional weight loss programs.
How similar studies have performed: Other studies on endoscopic weight loss devices have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Sydney, New South Wales and 1 other locations
- BMI Clinic Double Bay — Sydney, New South Wales, Australia (Recruiting)
- BMI Clinic Liverpool — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Adrian Sartoretto, Dr — The BMI Clinic
- Study coordinator: Christophe Naz
- Email: christophe.naz@bariatek-medical.com
- Phone: 0180206755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.