NCT00179036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

15.9 years

First QC Date

September 13, 2005

Last Update Submit

April 5, 2017

Conditions

Ischemia

Keywords

Blood supplyMesentery

Outcome Measures

Primary Outcomes (1)

  • To observe a difference in the magnetic activity between the normal and diseased smooth muscle of the small intestine

    2010

Secondary Outcomes (1)

  • Create mathematical and computer models of electrical activity of smooth muscle

    2010

Study Arms (2)

Good blood flow

Group without any ischemia to the small intestine

Poor blood flow

Group with partial ischemia to the small intestine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Normal subjects and those with diagnosed mesenteric ischemia

You may not qualify if:

  • Subjects who report a tendency toward claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Somarajan S, Muszynski ND, Cheng LK, Bradshaw LA, Naslund TC, Richards WO. Noninvasive biomagnetic detection of intestinal slow wave dysrhythmias in chronic mesenteric ischemia. Am J Physiol Gastrointest Liver Physiol. 2015 Jul 1;309(1):G52-8. doi: 10.1152/ajpgi.00466.2014. Epub 2015 Apr 30.

    PMID: 25930082DERIVED

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William O. Richards, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2000

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)