Biomagnetic Characterization of Gastric Dysrhythmias:Study 2 (SQUID)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178984
First received: September 13, 2005
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition Phase
Ischemia
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Biomagnetic Characterization of Gastric Dysrhythmias:Study 2

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • to observe a difference in the magnetic activity between the normal and diseased smooth muscle of the stomach and intestines. [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to specifically study the electrical activity of diabetics with an abnormal gastric emptying. [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Measurement of mesenteric ischemia [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2000
Estimated Study Completion Date: September 2013
Groups/Cohorts
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

Detailed Description:

The Squid magnetometer is a non-invasive investigational device that measures the electrical activity in the smooth muscle of the intestines. Volunteers with normal bowel activity, those with gastric problems, and diabetics with gastric problems will be studied under the SQuid to determine normal and abnormal activity. Diabetics with an abnormal gastric emptying study will be asked to participate.

  Eligibility

Ages Eligible for Study:   14 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 volunteers, those with stomach problems, and Diabetics with abnormal gastric emptying study

Exclusion Criteria:

  • Diabetics with a normal gastric emptying study
  • Participants with claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178984

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: Alan Bradshaw, PhD    615-322-0705    alan.bradshaw@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Leonard A. Bradshaw, Ph.D. Vanderbilt University Department of Physics and Surgery
  More Information

No publications provided

Responsible Party: Dr. Leonard A. Bradshaw, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178984     History of Changes
Other Study ID Numbers: 051175, 5RO1DK58697-05A2
Study First Received: September 13, 2005
Last Updated: June 24, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Blood supply
Mesentery

ClinicalTrials.gov processed this record on September 18, 2014