- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512512
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
June 30, 2010 updated by: Johns Hopkins University
This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure.
The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4
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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Maryland
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Baltimore, Maryland, United States, 21224
- Hopkins Bayview Medical Center
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Morbid Obese patients who are already approved for gastric bypass surgery.
Description
Inclusion Criteria:
- Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI>40 or BMI>35 with multiple medical co morbidities).
- Age greater than 18 years.
- Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).
Exclusion Criteria:
- Inability to give informed consent
- Women who are pregnant or in whom pregnancy status cannot be confirmed.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael A Schweitzer, M.D., Johns Hopkins University
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
June 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
August 6, 2007
First Submitted That Met QC Criteria
August 6, 2007
First Posted (Estimate)
August 7, 2007
Study Record Updates
Last Update Posted (Estimate)
July 1, 2010
Last Update Submitted That Met QC Criteria
June 30, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00007226
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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