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The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM

StatusRecruiting
PhaseNot applicable
Started2024-11-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Jun 1, 2026 → Jun 1, 2028
See other at-risk trials from Indiana University

Amendment history

2026-09-03
Study Status v5
Primary completion pushed: 2026-06-01 → 2028-06-01
Completion pushed: 2026-06-01 → 2028-06-01
2026-02-16
Study Status v4
Re-verified, no change to tracked fields
2025-01-08
Study Status v3
Start dateestimated 2024-10-30→confirmed 2024-11-07
2024-10-29
Study Status v2
Completion date2026-09-01→2026-06-01
Start date2024-08-30→2024-10-30
2024-08-02
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Completion date2027-06-01→2026-09-01
Start date2024-08-01→2024-08-30
Study sites0→1
Study arms0→1
InterventionsGastric Alimetry (Device)→Gastric Alimetry System (Device)
Secondary endpoints1 entry, revised
TheBody investigatorssurface willgastric alsomapping investigate whether changes in BSGM measures correlate with changes in symptoms and quality of life.(BSMG)
Primary endpoints1 to 5 entries
OurBMI-Adjusted primaryAmplitude objective(μV) Body isSurface toGastric evaluateMapping theRhythm safetyIndexTM and(GA-RI) Fed: feasibilityFasted BSGMAmplitude inRatio refractory(ff-AR) Principal gastroparesisGastric patients undergoing GFrequency SF-POEM.36
2024-07-02
Original filing
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.
Trial Details
NCT Number NCT06493032
Lead Sponsor Indiana University
Conditions Gastroparesis
Enrollment 20 participants
Start Date 2024-11-07
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-08