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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
ValenTx, Inc.
ClinicalTrials.gov Identifier:
NCT01207830
First received: September 21, 2010
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

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


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 Subjects

Resource links provided by NLM:


Further study details as provided by ValenTx, Inc.:

Primary Outcome Measures:
  • Device-related adverse events [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Performance [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Valentx Endo Bypass System
    Subject is implanted with the device for up to 3 years.
    Other Names:
    • Valentx
    • Endo Bypass System
    • EBS
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01207830

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

No publications provided

Responsible Party: Dr. Roberto Rumbaut, Hospital San Jose Tec de Monterrey
ClinicalTrials.gov Identifier: NCT01207830     History of Changes
Other Study ID Numbers: LA 2.2
Study First Received: September 21, 2010
Last Updated: December 1, 2010
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

Keywords provided by ValenTx, Inc.:
Obesity

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

ClinicalTrials.gov processed this record on October 21, 2014