Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.

Launched by BARIATEK MEDICAL · Apr 10, 2024

Keywords

ClinConnect Summary

The Clinical Feasibility Study of the BariTon™ System is looking at a new device designed to help people who are obese or overweight. This study aims to evaluate how safe and effective the BariTon™ device is in reducing weight for patients who have struggled with obesity for at least two years and have not seen success with other weight loss programs. The study is currently recruiting participants aged between 25 and 60 years, with a body mass index (BMI) between 30 and 40, which indicates varying levels of obesity.

To take part in this study, participants need to have maintained a stable weight (meaning their weight hasn’t changed by more than 5%) for at least three months before joining. They must also be willing to sign a consent form to show they understand the study and agree to participate. If eligible, participants can expect to follow specific study procedures and attend follow-up appointments to monitor their progress. This research is important as it could lead to new options for weight management in people facing obesity challenges.

Gender

ALL

Eligibility 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