Using Body Surface Gastric Mapping to Improve G-POEM Outcomes
The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
This study is testing if a new mapping technique can help doctors find the right patients with gastroparesis who would benefit from a specific procedure called G-POEM.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06493032 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Body Surface Gastric Mapping (BSGM) in identifying patients with gastroparesis who would benefit most from the G-POEM procedure. The researchers aim to evaluate the safety and feasibility of BSGM in patients undergoing G-POEM and to explore how BSGM can correlate with symptom improvement and quality of life. By supplementing existing studies with BSGM data, the investigators hope to identify patterns that could inform future research and treatment strategies for gastroparesis. The study will also compare BSGM's diagnostic performance with traditional gastric emptying scans.
Who should consider this trial
Good fit: Ideal candidates are patients with refractory gastroparesis who are clinically eligible for the G-POEM procedure.
Not a fit: Patients with gastroparesis due to spinal cord injuries or those unable to undergo BSGM testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with gastroparesis, improving their outcomes after G-POEM.
How similar studies have performed: While this approach is innovative, it builds on existing studies of G-POEM, suggesting potential for success based on prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients clinically eligible for G-Poem at our center. Exclusion Criteria: * • 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Mohammad Al-Haddad, MD — Indiana Unversity/Indiana University Health
- Study coordinator: Jacqueline Peterman
- Email: petermaj@iu.edu
- Phone: 317-278-9242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.