NCT00178984

Brief Summary

The purpose of this study is to use the Squid magnetometer (Superconducting QUantum Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach and intestines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

June 1, 2000

Completed
5.3 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
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2012

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

12.2 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 stomach and intestines.

    2010

Secondary Outcomes (2)

  • to specifically study the electrical activity of diabetics with an abnormal gastric emptying.

    2010

  • Measurement of mesenteric ischemia

    2010

Study Arms (2)

poor blood flow

Group with partial ischemia to the small intestine

Good blood flow

Group with normal blood flow, given different conditions to effect electrical currents in normal smooth muscle

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care clinic

You may qualify if:

  • Normal volunteers, those with stomach problems, and Diabetics with abnormal gastric emptying study

You may not qualify if:

  • Diabetics with a normal gastric emptying study
  • Participants 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

  • Leonard A. Bradshaw, Ph.D.

    Vanderbilt University Department of Physics and Surgery

    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

June 1, 2000

Primary Completion

August 10, 2012

Study Completion

August 10, 2012

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)