G-POEM vs PEG-J in Gastroparesis Patients - Trial NCT06372132
Access comprehensive clinical trial information for NCT06372132 through Pure Global AI's free database. This phase not specified trial is sponsored by Maastricht University Medical Center and is currently Recruiting. The study focuses on Gastroparesis. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
Maastricht University Medical Center
Timeline & Enrollment
N/A
Mar 14, 2024
Jan 01, 2028
Primary Outcome
Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06372132
Non-Device Trial