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Magnetogastrogram for Gastroparesis

N/A

Waitlist Available

Led By Leonard A Bradshaw, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children (ages 12-17) with functional dyspepsia

Total or partial gastrectomy patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 30

Awards & highlights

Study Summary

This trial is looking at a new way to assess bioelectrical activity in the gastrointestinal system in order to help characterize normal and pathologic physiology of the stomach.

Who is the study for?

This trial is for people aged 12-80 with conditions like gastroparesis, chronic nausea, or those who've had a gastrectomy. It includes diabetic patients and children with functional dyspepsia. Pregnant women, individuals over 80, those with claustrophobia, morbid obesity, cardiac arrhythmias or on anticoagulants cannot participate.Check my eligibility

What is being tested?

The study tests a noninvasive technique called magnetogastrogram (MGG) to assess gastric electrical activity without radiation exposure. The goal is to distinguish normal from abnormal gastric activity which could improve treatment for stomach disorders.See study design

What are the potential side effects?

Since MGG is noninvasive and doesn't involve drugs or radiation, significant side effects are not expected. However, the procedure requires lying still under equipment which might be uncomfortable for some participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a child aged 12-17 with stomach upset not caused by any known disease.

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I have had all or part of my stomach removed.

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I am between 12 and 80 years old.

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I have been diagnosed with idiopathic gastroparesis.

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I am a child aged 12-17 with ongoing nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach

Secondary outcome measures

Measurement of gastric slow wave propagation velocity in gastroparesis patients

Measurement of invasive serosal electromyogram before and after partial/total gastrectomy.

Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy.

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: GastroparesisExperimental Treatment1 Intervention

magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis

Group II: GastrectomyExperimental Treatment1 Intervention

magnetogastrogram Total or partial gastrectomy group

Group III: Functional dyspepsiaExperimental Treatment1 Intervention

magnetogastrogram Children with functional dyspepsia

Group IV: Control participantsExperimental Treatment1 Intervention

magnetogastrogram Group without any gastrointestinal diseases.

Group V: Chronic nauseaExperimental Treatment1 Intervention

magnetogastrogram Children with chronic nausea

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,042 Total Patients Enrolled

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

2,357 Previous Clinical Trials

4,315,036 Total Patients Enrolled

19 Trials studying Gastroparesis

3,269 Patients Enrolled for Gastroparesis

Leonard A Bradshaw, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

magnetogastrogram Clinical Trial Eligibility Overview. Trial Name: NCT03176927 — N/A

Gastroparesis Research Study Groups: Gastroparesis, Gastrectomy, Functional dyspepsia, Chronic nausea, Control participants

Gastroparesis Clinical Trial 2023: magnetogastrogram Highlights & Side Effects. Trial Name: NCT03176927 — N/A

magnetogastrogram 2023 Treatment Timeline for Medical Study. Trial Name: NCT03176927 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project seeking out participants who are at least twenty years old?

"This clinical trial has a patient age range from 12 to 80 years old, as indicated by the eligibility criteria."

Answered by AI

Is the recruitment of participants ongoing for this investigation?

"The clinicaltrials.gov listing indicates that this study, last updated on September 12th 2022 and originally posted December 1st 2012, is no longer recruiting participants. However, there are currently 48 other trials seeking patient enrollment at the moment."

Answered by AI

Is it possible to join this research project?

"Prospective participants of this trial must have been diagnosed with gastroparesis and be aged between 12 to 80 years. With a desired enrolment count of 150, recruitment is currently underway."

Answered by AI