Clinical Feasibility Study of the BariTon™ System in Obes... | NCT06317129

Studies
Clinical Feasibility Study of the BariTon™ System in Obese Patients

NCT06317129

Sponsor

BariaTek Medical

Status

Unknown status

Last Update Posted

Mar 19, 2024Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Endoscopic gastric restriction and biliodigestive diversion

Countries

Uzbekistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2024Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Jan 18, 2024

First Submission Date that Met QC Criteria

Mar 15, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BariTon™ System implantation	Experimental		Device: Endoscopic gastric restriction and biliodigestive diversion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic gastric restriction and biliodigestive diversion	Device	The BariTon™ is endoscopically implanted.	BariTon™ System implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety of the BariTon™	Number of patients with device retrieval procedure success	1 year
Safety of the BariTon™	Incidence of device related adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe Naz	Contact	+33.1.80.20.67.55		christophe.naz@bariatek-medical.com
Youssef Biadillah	Contact	+33.1.80.20.67.55		youssef.biadillah@bariatek-medical.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov	Recruiting	Tashkent			Uzbekistan

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided