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

September 21, 2010
September 21, 2010
August 2008
March 2009   (final data collection date for primary outcome measure)
Device-related adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Device performance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Feasibility Trial of ValenTx Endo Bypass System
A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients

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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Device: ValenTx Endo Bypass System
Patient is implanted with device and followed for 12 weeks
Other Names:
  • ValenTx
  • Endo Bypass System
  • EBS
Experimental: Device
Intervention: Device: ValenTx Endo Bypass System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01207804
FIM
No
Dr. Roberto Rumbaut, Hospital San Jose Tec de Monterrey
ValenTx, Inc.
Not Provided
Principal Investigator: Roberto Rumbaut, MD Hospital San Jose Tec
ValenTx, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP