Biomagnetic Characterization of Gastric Dysrhythmias:Study 2 | NCT00178984

Studies
Biomagnetic Characterization of Gastric Dysrhythmias:Study 2

NCT00178984

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 7, 2017Actual

Enrollment

78Actual

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
5R01DK058697	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

Jun 2000

Primary Completion Date

Aug 10, 2012Actual

Completion Date

Aug 10, 2012Actual

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 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.

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.

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

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

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 stomach and intestines.		2010

Secondary Outcomes

Measure	Description	Time Frame
to specifically study the electrical activity of diabetics with an abnormal gastric emptying.		2010
Measurement of mesenteric ischemia		2010

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Primary Care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonard A. Bradshaw, Ph.D.	Vanderbilt University Department of Physics and Surgery	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D007511	Ischemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided