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

Status Active, not recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT02954003
• Study type: Interventional
• Source: ValenTx, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2013
• Completion date: October 2018