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NCT06372132

G-POEM vs PEG-J in Gastroparesis Patients

'Treatment Outcome of Gastric Peroral Endoscopic Pyloromyotomy in Comparison With Percutaneous Endoscopic Gastrostomy With Jejunal Extension in Medically Refractory Gastroparesis: a Prospective Randomized Controlled Trial'
Maastricht University Medical Center·ClinicalTrials.gov·procedureRecruiting
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Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
G-POEM
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Maastricht University Medical Center
Location
Maastricht, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Mar 14, 2024
End date
Jan 01, 2028
Enrollment
50 participants
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
Attention to gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06372132
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.