The ValenTx Endo Bypass System in Obese Subjects | NCT02954003

Studies
The ValenTx Endo Bypass System in Obese Subjects

NCT02954003

Sponsor

ValenTx, Inc.

Status

Unknown status

Last Update Posted

Nov 3, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Endo Bypass System

Countries

Canada
Mexico

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2018Estimated

First Submitted Date

Sep 23, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 3, 2016Estimated

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

Nov 1, 2016

Last Update Posted Date

Nov 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.

Detailed Description

Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
Subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted device.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endo Bypass	Experimental	Subjects implanted with the investigational ValenTx Endo Bypass System	Device: Endo Bypass System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endo Bypass System	Device	Subject is implanted with the device for up to 3 years.	Endo Bypass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.	The proportion of subjects affected by SADEs during the 12 months following their device implant.	1 Year

Secondary Outcomes

Measure	Description	Time Frame
Mean 12 Month Weight Loss in Kilograms	Mean reduction in bodyweight in kilograms from the pre-implant baseline visit to the 12 month post-implant follow-up visit.	1 Year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Between 18- 60 years old.
BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes
Willing to give informed consent, and able to understand what this means.
Documented failure with non-surgical weight loss methods.
Willing to follow the study procedures and comply with the visits schedule.
Live within a reasonable distance of the research center and be able to attend routine follow up visits.

Exclusion Criteria

Pregnancy or intention to become pregnant during the course of the study.
Abnormal screening esophagogastroduodenoscopy findings
Prior esophageal, gastric or bariatric surgery.
Known allergies to any of the device materials.
Use of weight loss drugs, stimulants and/or herbal weight loss supplements.
Recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine.
Participation in another clinical trial within 60 days of the implant.
Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Roland Maude-Griffin	ValenTx, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph Healthcare		Hamilton	Ontario	L8N 4A6	Canada
Hopital Laval (IUCPQ)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided