- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207830
Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese Subjects
March 15, 2016 updated by: ValenTx, Inc.
A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Subjects
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Monterrey, Mexico
- Hospital San Jose Tec de Monterrey
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endo Bypass
Subjects implanted with the investigational ValenTx Endo Bypass System
|
Subject is implanted with the device for up to 3 years.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device-related adverse events
Time Frame: 1-3 years
|
1-3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device Performance
Time Frame: 1-3 years
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1-3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberto Rumbaut, M.D., Hospital San Jose Tec
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
September 21, 2010
First Submitted That Met QC Criteria
September 21, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Estimate)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LA 2.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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