Clinical Feasibility Study of the BariTon™ System in Obese Patients

Launched by BARIATEK MEDICAL · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the BariTon™ System, which is designed to help people with obesity. The main goal is to evaluate the safety of this device for patients who have struggled with their weight. If you're between the ages of 25 and 60, have a body mass index (BMI) between 30 and 40, and have been dealing with obesity for at least two years without success in weight loss programs, you might be eligible to participate. Participants should also have a stable weight for the past three months, meaning they haven’t lost or gained more than 5% of their body weight.

If you decide to take part in this study, you can expect to receive close monitoring and support throughout the process. You will need to give your written consent to participate and agree to follow the study’s procedures and follow-up appointments. This trial is currently recruiting participants, and it aims to gather valuable information that could help improve treatment options for obesity in the future.

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