Biomagnetic Signals of Intestinal Ischemia II - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

January 28, 2009

Start Date ^†

January 2000

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00179036 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Create mathematical and computer models of electrical activity of smooth muscle [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Biomagnetic Signals of Intestinal Ischemia II

Official Title ^†

Biomagnetic Signals of Intestinal Ischemia II

Brief Summary

The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

Detailed Description

The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, the investigators hope to identify abnormal disease states without surgery.

Study Phase

Phase I

Study Type ^†

Observational

Study Design ^†

Case Control, Cross-Sectional

Condition ^†

Ischemia

Intervention ^†

Study Arms / Comparison Groups

Group with normal blood flow
Group with abnormal blood flow

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

June 2010

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Normal subjects and those with diagnosed mesenteric ischemia

Exclusion Criteria:

Subjects who report a tendency toward claustrophobia

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Joan Kaiser, RN

615-343-5821

joan.kaiser@vanderbilt.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00179036

Responsible Party

Dr. William O. Richards, Vanderbilt University

Secondary IDs ^††

NIH RO1 DK 58197-05

Study Sponsor ^†

Vanderbilt University

Collaborators ^††

National Institutes of Health (NIH)

Investigators ^†

Principal Investigator:

William O. Richards, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.