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Compares treatment options for Esophageal Achalasia
Official title Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
ClinicalTrials.gov ID: NCT05899842
What this study is testing
What is Protein pump inhibitor therapy systematically?
Protein pump inhibitor therapy systematically is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for esophageal achalasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
You likely can't join if
- Patient with contraindications to PPIs
- Patient with mediastinal and esophageal neoplasia
- Patient with a history of Heller myotomy surgery
- Patients requiring any type of anti-reflux valve surgery
- The subject is in a period of exclusion determined by a previous study
- It is impossible to give the subject informed information
See the full eligibility criteria
- Patient with an indication for esophageal POEM for achalasia
- Patient with all types of achalasia with Eckardt score \> 3
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with contraindications to PPIs
- Patient with mediastinal and esophageal neoplasia
- Patient with a history of Heller myotomy surgery
- Patients requiring any type of anti-reflux valve surgery
- The subject is in a period of exclusion determined by a previous study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
- Montpellier, France
- Nîmes, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France; Montpellier, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.