Body Surface Gastric Mapping for Gastroparesis and G-POEM
This study is looking at how a medical device called the Gastric Alimetry System, which uses electrodes on your skin to measure stomach activity (Body Surface Gastric Mapping), can help people with gastroparesis. Gastroparesis is a condition where your stomach empties food too slowly. Researchers want to see if this mapping can help predict who will benefit most from a procedure called G-POEM (Gastric peroral endoscopic myotomy), which helps improve stomach emptying. They also want to understand how Body Surface Gastric Mapping can be used to track how well G-POEM works and potentially find new ways to help patients with gastroparesis. You may be eligible if you are an adult who is a candidate for G-POEM at the study center and are not pregnant or breastfeeding. This study is currently unclear on its recruitment status and plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 20 participants.
- What's involved
- You will have Body Surface Gastric Mapping measurements taken at the start of the study, and then again at 3 and 6 months. Each measurement session will last up to 5 hours.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the start of the study, with measurements taken at 3 and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mohammad Al-Haddad, MD · PRINCIPAL_INVESTIGATOR · Indiana Unversity/Indiana University Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)Baseline, 3 months,6 months, up to 5 hours.
A measure of the concentration of amplitude in the gastric frequency band over time (between 0 and 1), which characterizes the rhythmic stability of the recorded gastric activity; also adjusted for BMI.
- Principal Gastric FrequencyBaseline, 3 months,6 months, up to 5 hours.
Characterizes the frequency associated with stable, persistent gastric activity as defined by GA-R
- BMI-Adjusted Amplitude (μV)Baseline, 3 months,6 months, up to 5 hours.
characterizes the strength of the recorded gastric activity as an average of the whole-test amplitude, adjusted for BMI
- Fed: Fasted Amplitude Ratio (ff-AR)Baseline, 3 months,6 months, up to 5 hours.
characterizes the responsiveness to a meal stimulus, which is calculated as a ratio of the maximal 1-h average postprandial amplitude to the amplitude in the preprandial period.
- SF-36Baseline, 3 months,6 months, up to 5 hours.
a set of generic, coherent, and easily administered quality-of-life measures