The ValenTx Endo Bypass System in Obese Subjects

Not Applicable

• Conditions: Obesity

• Registration Number: NCT02954003
• Lead Sponsor: ValenTx, Inc.

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-10
• Study First Submitted: 2016-09-23
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-01
• Last Update Submitted: 2016-11-01
• Study First Posted: 2016-11-03
• Last Update Posted: 2016-11-03
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

St. Joseph Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Hopital Laval (IUCPQ); 🇨🇦 Quebec, Canada

Hospital San Jose Tec de Monterrey; 🇲🇽 Monterrey, NL, Mexico