ObesityNCT06317129
Clinical Feasibility Study of the BariTon™ System in Obese Patients
A study testing Endoscopic gastric restriction and biliodigestive diversion in people with Obesity, run by BariaTek Medical at 1 site in Uzbekistan.
Trial summary
Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endoscopic gastric restriction and biliodigestive diversion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUzbekistan
- Study dates
- 18 Jan 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site, 1 recruiting
- Recruiting
Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov
Tashkent
Abdurashid Abdukarimov, Dr
About this study
Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.
- Conditions
- Obesity
- Being tested
- Endoscopic gastric restriction and biliodigestive diversion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gastric restriction and biliodigestive diversionDevice
The BariTon™ is endoscopically implanted.
| Study group | Role | What they receive |
|---|---|---|
| BariTon™ System implantation | Experimental | Not described Receives: Device: Endoscopic gastric restriction and biliodigestive diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the BariTon™
Number of patients with device implantation procedure success
Measured: 3 months
Safety of the BariTon™
Incidence of device related adverse events
Measured: 3 months
Secondary outcomes (8)
Safety of the BariTon™
Number of patients with device retrieval procedure success
Measured: 1 year
Safety of the BariTon™
Incidence of device related adverse events
Measured: 1 year
Efficacy of the BariTon™
Assessment of clinical variables and other metrics
Measured: 1 year
Efficacy of the BariTon™
Changes and number of diabetes medication taken
Measured: 1 year
Efficacy of the BariTon™
Changes and number of statins medication taken
Measured: 1 year
Efficacy of the BariTon™
Changes and number of blood pressure lowering medication taken
Measured: 1 year
Efficacy of the BariTon™
Changes in weight related to quality of life (score change of IWQOL-Lite Questionnaire)
Measured: 1 year
Efficacy of the BariTon™
Changes in food craving (score change of CoEQ questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start18 Jan 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BariaTek Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317129
- Sponsor's protocol ID
- CP000005
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study of the BariTon™ System in Obese Patients
- ClinicalTrials.gov ID
- NCT06317129
- Acronym / sponsor ID
- CP000005
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BariaTek MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BariTon™ System implantation | Experimental | Device: Endoscopic gastric restriction and biliodigestive diversion |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic gastric restriction and biliodigestive diversionThe BariTon™ is endoscopically implanted. | Device | BariTon™ System implantation |
Primary outcome
Safety of the BariTon™
Time frame: 3 months
Number of patients with device implantation procedure success
Safety of the BariTon™
Time frame: 3 months
Incidence of device related adverse events
8 secondary outcomes
Safety of the BariTon™
Time frame: 1 year
Safety of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Efficacy of the BariTon™
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic gastric restriction and biliodigestive diversion in people with Obesity, run by BariaTek Medical at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Naz (+33.1.80.20.67.55, christophe.naz@bariatek-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the BariTon™ (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.