Evaluation of the BariTon™ System for treating obesity
Clinical Feasibility Study of the BariTon™ System in Obese Patients
NA · BariaTek Medical · NCT06317129
This study is testing a new device called the BariTon™ System to see if it can help people with obesity lose weight and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | BariaTek Medical (industry) |
| Locations | 1 site (Tashkent) |
| Trial ID | NCT06317129 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of the BariTon™ System, which involves endoscopic gastric restriction and biliodigestive diversion, in obese patients. Participants will be assessed for their eligibility based on specific criteria, including age, BMI, and weight stability. The study aims to determine the effectiveness of this innovative device in managing obesity and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 60 with a BMI between 30 and 40 who have struggled with obesity for at least two years.
Not a fit: Patients with a BMI outside the specified range or those who have not experienced weight stability may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new option for effective weight management in obese patients.
How similar studies have performed: While this approach is innovative, similar studies evaluating endoscopic interventions for obesity have shown promising results.
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
Tashkent
- Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov — Tashkent, Uzbekistan (RECRUITING)
Study contacts
- Study coordinator: Christophe Naz
- Email: christophe.naz@bariatek-medical.com
- Phone: +33.1.80.20.67.55
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.
Conditions: Obesity