The ValenTx Endo Bypass System in Obese Subjects

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02954003
• Other study ID #: EN 2.3
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: October 2018

Study information

• Verified date: November 2016
• Source: ValenTx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en SaludCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria

1. Between 18- 60 years old.

2. 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

3. Willing to give informed consent, and able to understand what this means.

4. Documented failure with non-surgical weight loss methods.

5. Willing to follow the study procedures and comply with the visits schedule.

6. Live within a reasonable distance of the research center and be able to attend routine follow up visits.

Exclusion Criteria

1. Pregnancy or intention to become pregnant during the course of the study.

2. Abnormal screening esophagogastroduodenoscopy findings

3. Prior esophageal, gastric or bariatric surgery.

4. Known allergies to any of the device materials.

5. Use of weight loss drugs, stimulants and/or herbal weight loss supplements.

6. 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.

7. Participation in another clinical trial within 60 days of the implant.

8. Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Endo Bypass System
Subject is implanted with the device for up to 3 years.

Locations

Country	Name	City	State
Canada	St. Joseph Healthcare	Hamilton	Ontario
Canada	Hopital Laval (IUCPQ)	Quebec
Mexico	Hospital San Jose Tec de Monterrey	Monterrey	NL

Sponsors (1)

Lead Sponsor	Collaborator
ValenTx, Inc.

Countries where clinical trial is conducted

Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No