Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-14
2028-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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G-POEM
G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
PEG-J
G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
Interventions
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G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months
* 18 years old
Exclusion Criteria
* Medical history of stomach surgery in which resection of antrum and/ or pylorus took place
* Medical history of surgical or laparoscopic pyloromyotomy
* Gastric bypass
* Current opioid use
* Pregnancy
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL85305.068.23
Identifier Type: -
Identifier Source: org_study_id
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