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

ValenTx, Inc.1 site in 1 country10 target enrollmentMarch 2010

ConditionsObesity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity
Sponsor: ValenTx, Inc.
Enrollment: 10
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 this 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 subjects

Detailed Description

This is a single center, open label, feasibility study whose major aim is to determine the feasibility (based on safety, efficacy and device performance) of the ValenTx Endo Bypass system with the replaceable sleeve. Also, the use of a tag replacement device may be developed and implemented should individual attachment tags need replaced following the initial implant.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

February 2012

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
•Subject has a BMI \>35 kg/m2 and \<= 50 kg/m2, with or without co-morbid 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 (Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg condom plus diaphragm. If screening pregnancy test is done greater than 7 days before implant, women of childbearing potential must have another serum pregnancy test result before implantation. Any woman becoming pregnant during the treatment period must withdraw from the study)
•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 0
•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 0 (implant day)
•Prolonged steroid use
•Hep C or HIV positive
•Known allergies to any of the device materials