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Feasibility Trial of ValenTx Endo Bypass System

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ClinicalTrials.gov Identifier: NCT01207804
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
ValenTx, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Device: ValenTx Endo Bypass System Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Device Device: ValenTx Endo Bypass System
Patient is implanted with device and followed for 12 weeks
Other Names:
  • ValenTx
  • Endo Bypass System
  • EBS



Primary Outcome Measures :
  1. Device-related adverse events [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Device performance [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ValenTx, Inc.
ClinicalTrials.gov Identifier: NCT01207804     History of Changes
Other Study ID Numbers: FIM
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by ValenTx, Inc.:
Obesity