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Procedure
Gastric Mapping for Gastroparesis
N/A
Recruiting
Led By Mohammad Al-Haddad, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients with abdominal drains or tubes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months,6 months, up to 5 hours.
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if Body Surface Gastric Mapping can help identify the best candidates for a G-POEM procedure and how it can be used for patients with gastroparesis symptoms.
Who is the study for?
This trial is for individuals with gastroparesis, a condition where the stomach empties too slowly. Participants should be candidates for or have had a G-POEM procedure. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study is testing if Body Surface Gastric Mapping, a non-invasive test, can predict who will benefit from G-POEM (a procedure to help food leave the stomach faster) and monitor its success in patients with gastroparesis.
What are the potential side effects?
Since this trial involves diagnostic mapping rather than medication or invasive treatment, side effects are likely minimal but may include discomfort at sensor sites on the body.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a drain or tube placed in my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months,6 months, up to 5 hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months,6 months, up to 5 hours.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BMI-Adjusted Amplitude (μV)
Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)
Fed: Fasted Amplitude Ratio (ff-AR)
+2 moreSecondary study objectives
Body surface gastric mapping (BSMG)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Body Surface Gastric MappingExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,864 Total Patients Enrolled
10 Trials studying Gastroparesis
7,064 Patients Enrolled for Gastroparesis
Mohammad Al-Haddad, MDPrincipal InvestigatorIndiana Unversity/Indiana University Health
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Gastroparesis
75 Patients Enrolled for Gastroparesis