Feasibility Trial of ValenTx Endo Bypass System

NCT01207804 | Completed

• 1 other identifier: FIM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Device-related adverse events

  12 weeks

Secondary Outcomes (1)

• Device performance

  12 weeks

Study Arms (1)

Device

EXPERIMENTAL

Device: ValenTx Endo Bypass System

Interventions

ValenTx Endo Bypass System DEVICE

Patient is implanted with device and followed for 12 weeks

Also known as: ValenTx, Endo Bypass System, EBS

Device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ValenTx, Inc.: lead

Study Sites (1)

Hospital San Jose Tec de Monterrey

Monterrey, 64710, Mexico

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Rumbaut, MD

  Hospital San Jose Tec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

ME (1)