Feasibility Trial of ValenTx Endo Bypass System

ValenTx

Status

Completed

Conditions

Obesity

Treatments

Device: ValenTx Endo Bypass System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01207804

FIM

Details and patient eligibility

About

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.

Full description

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

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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 1.
Prolonged steroid use
Hep C or HIV positive
Known allergies to any of the device materials
Use of weight loss medication or an investigational drug or device within 2 months prior to enrolment and throughout the study period.
Recent or ongoing cancer, history of severe renal, hepatic, cardiovascular or pulmonary disease or transplants
Inability to tolerate anti-inflammatory medications
Evidence of psychiatric problems or dietary habits that would contraindicate study treatment;
Active drug or alcohol addiction within 12 months of enrolment and throughout the study duration.
Prior history of inflammatory diseases of the GI tract, (e.g., esophagitis, varices, gastric or duodenal ulceration, or Crohn's disease; congenital or acquired GI anomalies, e.g., bowel strictures)
Ongoing treatment with anticoagulants, steroids, aspirin, NSAIDs, or other gastric irritants within 1 month prior to enrollment and throughout the study period.
Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigation drug or device.