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

NCT ID: NCT06360679

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2025-06-01

Brief Summary

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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BariTon™ System implantation

Group Type EXPERIMENTAL

Endoscopic gastric restriction and biliodigestive diversion

Intervention Type DEVICE

The BariTon™ is endoscopically implanted and retrieved once treatment is completed

Interventions

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Endoscopic gastric restriction and biliodigestive diversion

The BariTon™ is endoscopically implanted and retrieved once treatment is completed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BariaTek Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Sartoretto, Dr

Role: PRINCIPAL_INVESTIGATOR

The BMI Clinic

Locations

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BMI Clinic Double Bay

Sydney, New South Wales, Australia

Site Status RECRUITING

BMI Clinic Liverpool

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Christophe Naz

Role: CONTACT

0180206755 ext. 33

Youssef Biadillah

Role: CONTACT

0180206755 ext. 33

Facility Contacts

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Adrian Sartoretto, Dr

Role: primary

0290534688 ext. 61

Adrian Sartoretto, Dr

Role: primary

0290534688 ext. 61

Other Identifiers

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CIP000004

Identifier Type: -

Identifier Source: org_study_id

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