NCT06360679

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 11, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 7, 2024

Last Update Submit

April 10, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Safety of the BariTon™

    Number of patients with device implantation procedure success

    3 months

  • Safety of the BariTon™

    Incidence of device related adverse events

    3 months

Secondary Outcomes (8)

  • Safety of the BariTon™

    1 year

  • Safety of the BariTon™

    1 year

  • Efficacy of the BariTon™

    1 year

  • Efficacy of the BariTon™

    1 year

  • Efficacy of the BariTon™

    1 year

  • +3 more secondary outcomes

Study Arms (1)

BariTon™ System implantation

EXPERIMENTAL
Device: Endoscopic gastric restriction and biliodigestive diversion

Interventions

Endoscopic gastric restriction and biliodigestive diversionDEVICE

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

BariTon™ System implantation

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects aged between 25 and 60 years inclusive
  • 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
  • Stable weight, i.e. \< 5% change in body weight for minimum of 3 months prior to enrolment
  • Willing and able to provide written informed consent
  • Willing and able to comply with the study procedures and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BMI Clinic Double Bay

Sydney, New South Wales, 2028, Australia

RECRUITING

BMI Clinic Liverpool

Sydney, New South Wales, 2170, Australia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian Sartoretto, Dr

    The BMI Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Naz

CONTACT

0180206755christophe.naz@bariatek-medical.com

Youssef Biadillah

CONTACT

0180206755youssef.biadillah@bariatek-medical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

April 11, 2024

Study Start

January 29, 2024

Primary Completion

October 1, 2024

Study Completion

June 1, 2025

Last Updated

April 11, 2024

Record last verified: 2024-03

Locations

AU(2)