Clinical Trial

G-POEM vs PEG-J in Gastroparesis Patients

Recruiting
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Summary
Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.
Trial Details
NCT Number NCT06372132
Lead Sponsor Maastricht University Medical Center
Conditions Gastroparesis
Enrollment 50 participants
Start Date 2024-03-14
Primary Completion 2027-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-17