The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
ConditionGastroparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Patients clinically eligible for G-Poem at our center.
Disqualifiers
• Pregnant or breast-feeding
Patients with gastroparesis due to spinal cord injuries due to difficulties in conducting the BSGM. Of note, we rarely see gastroparesis in this context.
Inability to perform BSGM: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
Patients with abdominal drains or tubes
Trial design
Design model
Single group
Treatments tested in this trial
Gastric Alimetry System
Devicemedical device that uses a large sheet of electrodes to assess gastric motility
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Body Surface Gastric MappingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)
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.
Time frame
Baseline, 3 months,6 months, up to 5 hours.2
Principal Gastric Frequency
Characterizes the frequency associated with stable, persistent gastric activity as defined by GA-R
Time frame
Baseline, 3 months,6 months, up to 5 hours.3
BMI-Adjusted Amplitude (μV)
characterizes the strength of the recorded gastric activity as an average of the whole-test amplitude, adjusted for BMI
Time frame
Baseline, 3 months,6 months, up to 5 hours.4
Fed: Fasted Amplitude Ratio (ff-AR)
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.
Time frame
Baseline, 3 months,6 months, up to 5 hours.Secondary outcomes
1
Body surface gastric mapping (BSMG)
enables accurate cutaneous gastric bioelectrical recording and provides valuable insights into the pathophysiology of gastric dysmotility in addition to gastric emptying measurements
Time frame
Baseline, 3 months,6 months, up to 5 hours.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov