Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04112693
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 years and above;
* Woman of child-bearing age, if using active (oral contraceptive pill, intrauterine device, contraceptive implant) and/or mechanical (condom, diaphragm) contraceptive method;
* Treatment-naive (no pneumatic dilation, botox injection, Heller's myotomy) patient with HRM-diagnosed achalasia in whom POEM is indicated;
* Thorough oral and written information about the protocol has been provided and patient's consent to participate in the study has been obtained;
* The patient is insured under the French social security system.
Exclusion Criteria:
* Active anticoagulant treatment or coagulation disorder
* Past history of achalasia treatment (pneumatic dilation, botox injection, Heller's myotomy)
* Pregnancy or breastfeeding
* Patient under trusteeship, guardianship, placed under judicial protection, and/or unable to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04112693
Study Brief:
Protocol Section:
NCT04112693