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The ValenTx Endo Bypass System in Obese Subjects

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Endo Bypass System

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

St. Joseph Healthcare
Hopital Laval (IUCPQ)
Hospital San Jose Tec de Monterrey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endo Bypass

Arm Description

Subjects implanted with the investigational ValenTx Endo Bypass System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02954003

First Posted

September 23, 2016

Last Updated

November 1, 2016

Sponsor

ValenTx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02954003

Brief Title

The ValenTx Endo Bypass System in Obese Subjects

Official Title

An Open Label Trial of the Safety and Effectiveness of the ValenTx Endo Bypass System and Use of the Endoscopic Anchor Placement Device in Obese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ValenTx, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Weight Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endo Bypass

Arm Type

Experimental

Arm Description

Subjects implanted with the investigational ValenTx Endo Bypass System

Intervention Type

Device

Intervention Name(s)

Endo Bypass System

Other Intervention Name(s)

ValenTx System

Intervention Description

Subject is implanted with the device for up to 3 years.

Primary Outcome Measure Information:

Title

The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.

Description

The proportion of subjects affected by SADEs during the 12 months following their device implant.

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Mean 12 Month Weight Loss in Kilograms

Description

Mean reduction in bodyweight in kilograms from the pre-implant baseline visit to the 12 month post-implant follow-up visit.

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roland Maude-Griffin

Organizational Affiliation

ValenTx, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

St. Joseph Healthcare

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Hopital Laval (IUCPQ)

City

Quebec

Country

Canada

Facility Name

Hospital San Jose Tec de Monterrey

City

Monterrey

State/Province

ZIP/Postal Code

64710

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

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The ValenTx Endo Bypass System in Obese Subjects

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