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

April 10, 2024 updated by: BariaTek Medical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2028
        • Recruiting
        • BMI Clinic Double Bay
        • Contact:
      • Sydney, New South Wales, Australia, 2170
        • Recruiting
        • BMI Clinic Liverpool
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BariTon™ System implantation
Device: Endoscopic gastric restriction and biliodigestive diversion
The BariTon™ is endoscopically implanted and retrieved once treatment is completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the BariTon™
Time Frame: 3 months
Number of patients with device implantation procedure success
3 months
Safety of the BariTon™
Time Frame: 3 months
Incidence of device related adverse events
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BariaTek Medical

Investigators

  • Principal Investigator: Adrian Sartoretto, Dr, The BMI Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP000004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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