An interventional study of Gastric Alimetry System in Gastroparesis, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
Among 15 studies in Gastroparesis by Indiana University — 7 open to participants now, 8 under way, none of them phase 3. Gastroparesis · Indiana University.
Among the 15 studies in Gastroparesis by Indiana University, this one is the only one that started in 2024, is one of 7 with no phase, and was the 11th registered.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
This study's planned enrollment of 20 is below the median of 42 across 215 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →7 of the 15 studies in Gastroparesis by Indiana University are open now, in 1 country. Each count lists the studies.
Of the 50 Gastroparesis studies recruiting now, 25 (50%) set no upper age limit and 15 (30%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2024.
Median enrollment 32 across the 8 interventional studies, 158 across the 7 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
3 of the studies in Gastroparesis by Indiana University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT02165059Indiana UniversityGI Neuromuscular Pathology Prospective Registry | 2026-12 |
| NCT04282317Indiana UniversityMagnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis | 2026-12-31 |
Among the 15 studies in Gastroparesis by Indiana University, from their registry updates:
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.
The aim of this protocol is to build on the investigators currently approved study to evaluate the outcomes and predictors of success of Gastric peroral endoscopic myotomy (G-POEM). The investigators plan to incorporate BSGM in determining the treatment success after G-POEM in patients with refractory gastroparesis and potentially identify a phenotype of gastroparesis patients who may respond more favorably to G-POEM based on their baseline BSGM profile. The currently approved G-POEM study (IRB #1708840627 and ClinicalTrials.gov ID NCT04434781) at our center tracks patients' symptoms and quality of life at baseline and post G-POEM. the investigators plan to supplement the existing study by adding BSGM variables. Although the investigators have specific outcomes identified, the investigators would like to stress that this is a pilot study that will serve to identify patterns and trends that could be studied further in the future using larger cohorts of patients.
The investigators' primary objective is to evaluate the safety and feasibility BSGM in refractory gastroparesis patients undergoing G-POEM.
the investigators will also investigate whether changes in BSGM measures correlate with changes in symptoms and quality of life.
Additionally, the investigators' aim to compare the diagnostic performance of BSGM, and gastric emptying scans as depicted on scintigraphy.
The investigators' primary aim is to assess the feasibility and safety of in gastroparesis patients undergoing G-POEM. Clinical success is defined as improvement in GCSI by 1 point or more compared to baseline.
The investigators will report four spectral metrics, each profiling distinct features of gastric function:
Although not directly related to this outcome, the investigators will continue our symptom analysis (as has been previously done under the existing G-POEM protocol) that includes both the pattern and severity of individual symptoms, such as vomiting, reflux, and belching. The investigators will continue to assess patient quality of life using standardized questionnaires (SF-36) at baseline and 3 months post-G-POEM as is currently done with the existing protocol.
This is an addition to an existing study protocol. The study will involve patients with refractory gastroparesis (proven on a 4-hour solid-phase gastric emptying scan, along with limited or no response (or intolerance) to at least 3 months of lifestyle adjustments, dietary modifications, and medications) who will undergo G-POEM. BSGM will be used to assess gastric motility before and after the procedure. This design allows for the collection of data at multiple time points to assess changes in BSGM phenotypes, gastroparesis symptoms, and other relevant variables over time.
The study team will enroll 20 participants who will undergo BSGM at baseline prior to G-POEM procedure and then again 3-6 months after G-POEM. The study team plan to contact participants prior to their standard of care clinic visit to ensure participants meet eligibility criteria. The study team will also explain the study over the phone using the telephone script that has been approved (Appendix 1). If they are interested in the study, the study team will schedule them for BSGM and go over prep instructions. Once the participant arrives in clinic, teh study team will consent in-person.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant or breast-feeding
Device: Gastric Alimetry System
medical device that uses a large sheet of electrodes to assess gastric motility
Also known as: Body Surface Gastric Mapping, BSMG, Electrogastrography System
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.
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.
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.
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.
SF-36
a set of generic, coherent, and easily administered quality-of-life measures
Time frame: Baseline, 3 months,6 months, up to 5 hours.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jun 2028, 42 months after the start.
Of 56 non-industry interventional studies with no phase under Gastroparesis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 59. This study's planned 42 months is above that.
Counting every sponsor, half of 65 studies reached it within 28 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.