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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT04578769
Eligibility Criteria:
Inclusion Criteria:
* diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score \>3
* Their age is ≥14years and ≤70 years
* Able to give written consent
Exclusion Criteria:
* undergone previous surgical treatments
* had contra-indication to general anesthesia
* previous surgery of the mediastinum, stomach, or esophagus;
* Pregnant or lactating female
* type III achalasia
* current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio \>1.6)
* hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus
* esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
70 Years
Study:
NCT04578769
Study Brief:
Protocol Section:
NCT04578769