Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese Subjects

ValenTx

Status

Completed

Conditions

Obesity

Treatments

Device: Endo Bypass System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01207830

LA 2.2

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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
Use of weight loss medication within 2 months prior to enrollment 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 enrollment 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 0) or ongoing clinical trial or current or past usage (within 60 days of study day 0) of investigation drug or other device