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

Obesity Clinical Trial

Official title:

Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360679
• Other study ID #: CIP000004
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: BariaTek Medical
• Contact: Christophe Naz
• Phone: 0180206755
• Email: christophe.naz[@]bariatek-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Device:
• Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted and retrieved once treatment is completed

Locations

Country	Name	City	State
Australia	BMI Clinic Double Bay	Sydney	New South Wales
Australia	BMI Clinic Liverpool	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
BariaTek Medical

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the BariTon™	Number of patients with device implantation procedure success	3 months
Primary	Safety of the BariTon™	Incidence of device related adverse events	3 months
Secondary	Safety of the BariTon™	Number of patients with device retrieval procedure success	1 year
Secondary	Safety of the BariTon™	Incidence of device related adverse events	1 year
Secondary	Efficacy of the BariTon™	Assessment of clinical variables and other metrics (exploratory)	1 year
Secondary	Efficacy of the BariTon™	Changes and number of diabetes medication taken	1 year
Secondary	Efficacy of the BariTon™	Changes and number of statins medication taken	1 year
Secondary	Efficacy of the BariTon™	Changes and number of blood pressure lowering medication taken	1 year
Secondary	Efficacy of the BariTon™	Score changes in Weight related Quality of Life using IWQOL-Lite Questionnaire	1 year
Secondary	Efficacy of the BariTon™	Score changes in food craving using CoEQ Questionnaire	1 year