Realistic Models of Gastrointestinal Bioelectromagnetism - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00178997

Purpose

The purpose of this study is to look at the electrical activity present in healthy and diseased smooth muscle of the intestines; and develop both mathematical and computer models.

Condition	Phase
Ischemia	Phase I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Realistic Models of Gastrointestinal Bioelectromagnetism

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

To observe a difference in the electrical activity between normal and diseased smooth muscle of the intestines. [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To create both mathematical and computer models of the electrical activity of the intestines. [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	February 2004
Estimated Study Completion Date:	May 2009

Groups/Cohorts
A Group with poor blood flow to the smooth muscle of the intestines
B Group with normal blood flow compared to another

Detailed Description:

The Superconducting QUantum Interference Device (SQUID)is a large cylinder machine located in a large shielded room that measures magnetic activity of the intestines. Subjects will be asked to lie underneath and get recordings of the electrical activity of their intestines. They will also be asked to have a CT scan done. From these two procedures, the mathematical and computer models will be developed to determine the difference between normal bowels and those that do not have adequate blood supply.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

Normal subjects and those with diseased bowel

Exclusion Criteria:

Subjects with claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178997

Contacts

Contact: Joan Kaiser, RN

615-343-5821

joan.kaiser@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt UNiversity Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Joan Kaiser, RN 615-343-5821 joan.kaiser@vanderbilt.edu
Contact: William O Richards, MD 615-322-7555 bill.richards@vanderbilt.edu
Principal Investigator: Andrew J Pullan, PhD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Andrew J Pullan

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Andrew Pullan )
Study ID Numbers:	040014, 5RO1DK64775-02
Study First Received:	September 13, 2005
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00178997
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:

Blood supply
Mesentery

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009