A New International Scheme for the Classification and Management of Clinical Outcomes Post-gastric Peroral Endoscopic Myotomy.
Yervant Ichkhanian, Marita Salame, John M Wo...
https://pubmed.ncbi.nlm.nih.gov/40378985/Actively Recruiting
Led by Indiana University · Updated on 2026-02-18
75
Participants Needed
1
Research Sites
N/A
Total Duration
Gastroparesis is a stomach condition where food moves slowly from the stomach to the intestines, causing symptoms like nausea, vomiting, weight loss, and malnutrition. Researchers are studying Gastric Per-Oral Endoscopic Myotomy G-POEM, a less invasive procedure that creates a cut in the stomach muscle to help with gastric emptying. This observational study aims to understand the effects of this procedure on gastroparesis and improve patient care. G-POEM is performed without external incisions using an endoscope to access and treat the stomach muscle controlling emptying. This study collects data over a long period to observe changes in symptoms and gastric function following the procedure. Participants are referred for endoscopic treatment and observed over several months to years. Participants will have their symptoms and gastric emptying function assessed through surveys and gastric emptying scans at baseline and at multiple points up to 60 months after the procedure. Researchers track changes in the Gastroparesis Cardinal Symptom Index, Patient Assessment of Gastrointestinal Disorders symptom severity, and health-related quality of life. The study is observational and involves no experimental treatments beyond standard care management and follow-up assessments.
CONDITIONS
Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
J
Jacque Peterman
M
Mohammad Al-Haddad, MD
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Indiana University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo the endoscopic procedure known as Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the treatment of gastroparesis.
1 visit (in-person)
Duration - Up to 60 months
Participants are monitored to assess changes in symptoms and gastric emptying after the G-POEM procedure.
Visits at 1, 3, 6, 12, 24, 36, 48, and 60 months post-procedure
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Yervant Ichkhanian, Marita Salame, John M Wo...
https://pubmed.ncbi.nlm.nih.gov/40378985/Marita Salame, Yervant Ichkhanian, Nwal Hadaki...
https://pubmed.ncbi.nlm.nih.gov/39983999/Indiana University
Lead Sponsor