Clinical Feasibility Study of the BariTon™ System in Obese Patients

NCT ID: NCT06317129

Last Updated: 2024-03-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BariTon™ System implantation

Group Type EXPERIMENTAL

Endoscopic gastric restriction and biliodigestive diversion

Intervention Type DEVICE

The BariTon™ is endoscopically implanted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic gastric restriction and biliodigestive diversion

The BariTon™ is endoscopically implanted.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BariaTek Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov

Tashkent, , Uzbekistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Uzbekistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christophe Naz

Role: CONTACT

+33.1.80.20.67.55

Youssef Biadillah

Role: CONTACT

+33.1.80.20.67.55

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abdurashid Abdukarimov, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP000005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Whole Body Vibration After Bariatric Surgery
NCT05695599 ACTIVE_NOT_RECRUITING NA