NCT00178997

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2004

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

February 1, 2004

Completed
1.6 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
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

6.6 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 electrical activity between normal and diseased smooth muscle of the intestines.

    2011

Secondary Outcomes (1)

  • To create both mathematical and computer models of the electrical activity of the intestines.

    2011

Study Arms (2)

Good blood flow

Group without ischemia to the small intestine

Poor blood flow

Groups that have partial ischemia to their small intestine

Eligibility Criteria

Age18 Years - 65 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 diseased bowel

You may not qualify if:

  • Subjects with claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt UNiversity Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leo Cheng

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

February 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)