Feasibility Trial of ValenTx Endo Bypass System

This study has been completed.
Sponsor:
Information provided by:
ValenTx, Inc.
ClinicalTrials.gov Identifier:
NCT01207804
First received: September 21, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Device: ValenTx Endo Bypass System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients

Resource links provided by NLM:


Further study details as provided by ValenTx, Inc.:

Primary Outcome Measures:
  • Device-related adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device performance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Device: ValenTx Endo Bypass System
Patient is implanted with device and followed for 12 weeks
Other Names:
  • ValenTx
  • Endo Bypass System
  • EBS

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207804

Locations
Mexico
Hospital San Jose Tec de Monterrey
Monterrey, Mexico, 64710
Sponsors and Collaborators
ValenTx, Inc.
Investigators
Principal Investigator: Roberto Rumbaut, MD Hospital San Jose Tec
  More Information

No publications provided

Responsible Party: Dr. Roberto Rumbaut, Hospital San Jose Tec de Monterrey
ClinicalTrials.gov Identifier: NCT01207804     History of Changes
Other Study ID Numbers: FIM
Study First Received: September 21, 2010
Last Updated: September 21, 2010
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

Keywords provided by ValenTx, Inc.:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014