Biomagnetic Signals of Intestinal Ischemia II | NCT00179036

Studies
Biomagnetic Signals of Intestinal Ischemia II

NCT00179036

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 7, 2017Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Ischemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK058197	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2017

Last Update Posted Date

Apr 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alan Bradshaw, Research Assistant Professor, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Good blood flow		Group without any ischemia to the small intestine
Poor blood flow		Group with partial ischemia to the small intestine

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To observe a difference in the magnetic activity between the normal and diseased smooth muscle of the small intestine		2010

Secondary Outcomes

Measure	Description	Time Frame
Create mathematical and computer models of electrical activity of smooth muscle		2010

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal subjects and those with diagnosed mesenteric ischemia

Exclusion Criteria:

Subjects who report a tendency toward claustrophobia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William O. Richards, MD	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25930082	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms