A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients

ValenTx, Inc.1 site in 1 country12 target enrollmentAugust 2008

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: ValenTx, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Device-related adverse events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.

Detailed Description

This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

May 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ValenTx, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between 18 and 55 years of age
•\>=35 kg/m2 and \<= 50 kg/m2, with or without comorbid conditions(s).
•Documented failure with non-surgical weight loss methods
•Willing to comply with study procedures and visit schedule
•Willing and able to provide Informed Consent

Exclusion Criteria

•Pregnancy or intention of becoming pregnant within the study duration.
•Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach.
•Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia.
•Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (\> 3 cm).
•IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 1
•Unexplained anaemia, Pancreatitis, Portal hypertension, Esophagitis or Barrett's esophagus, known gallstones or anomalies of the GI tract
•Any bodily infections within 30 days of study day
•Prolonged steroid use
•Hep C or HIV positive
•Known allergies to any of the device materials