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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00512512
Other study ID # NA_00007226
Secondary ID
Status Completed
Phase N/A
First received August 6, 2007
Last updated June 30, 2010
Start date June 2007
Est. completion date June 2009

Study information

Verified date July 2009
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date June 2009
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI>40 or BMI>35 with multiple medical co morbidities).

2. Age greater than 18 years.

3. Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).

Exclusion Criteria:

1. Inability to give informed consent

2. Women who are pregnant or in whom pregnancy status cannot be confirmed.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Transoral Endoscopic Liver Biopsy
Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass

Locations

Country Name City State
United States Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Steele K, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible transgastric peritoneoscopy and liver biopsy: a feasibility study in human beings (with videos). Gastrointest Endosc. 2008 Jul;68(1):61-6. doi: 10.1016/j.gie.2007.09.040. Epub 2008 Mar 4. — View Citation

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