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Interest of systematic treatment with PPI after endoscopic myotomy compared to PPI treatment in case of symptoms in prevention of gastroesophageal reflux after POEM for esophageal achalasia. Randomized open-label clinical trial
EU CTIS ID: 2022-500218-25-01
What this study is testing
To evaluate the impact of routine PPI therapy for 12 months versus PPI therapy if indicated on the rate of acid reflux at 6 months in patients who received POEM for esophageal achalasia
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient with an indication for esophageal POEM for achalasia
- Patient with all types of achalasia with Eckardt score > 3
- Patient with free and informed consent.
- Patient affiliated or beneficiary of a health insurance plan.
- Adult patient (≥18 years old).
You likely can't join if
- Patients with contraindications to PPIs (Specify major ICs)
- Patient with mediastinal and esophageal neoplasia
- Patients with a history of Heller myotomy surgery
- Patients requiring any type of anti-reflux valve surgery
- Patient in an exclusion period determined by another study.
- Patient under court protection, guardianship or curatorship.
See the full eligibility criteria
- Patient with an indication for esophageal POEM for achalasia
- Patient with all types of achalasia with Eckardt score > 3
- Patient with free and informed consent.
- Patient affiliated or beneficiary of a health insurance plan.
- Adult patient (≥18 years old).
- Patients with contraindications to PPIs (Specify major ICs)
- Patient with mediastinal and esophageal neoplasia
- Patients with a history of Heller myotomy surgery
- Patients requiring any type of anti-reflux valve surgery
- Patient in an exclusion period determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient for whom it is impossible to give informed information.
- Pregnant, parturient, or breastfeeding patient.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.