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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02055469
Eligibility Criteria:
Inclusion Criteria:
* Patients with achalasia diagnosed on HRM criteria, with or without previous treatment
* Written ICF signed voluntarily before the first trial-related activity.
* Male or female, aged 18-70
* If the subject is a woman of childbearing potential, she must have a negative urine pregnancy test before the start of assessments
Exclusion Criteria:
* Any abnormal oesophageal motility finding that is not consistent with achalasia
* History of gastrointestinal tract surgery, fundoplication, endoscopic anti reflux procedure or any other recent abdominal operation in the last 6 months
* Major psychiatric, neurological, respiratory, liver, haemorrhagic and cardiac disorders, malignancies
* Pregnancy
* Subjects with a documented history of long segment (\>3 cm) Barrett's oesophagus, large (\> 3 cm) hiatus hernia, structural abnormalities of oesophagus (i.e. Rings, webs, scleroderma)
* Use of prokinetic medication less than 7 days before the start of the study
* Any condition that in the opinion of the Investigator would complicate or compromise the trial or the well-being of the subject.
* Evidence of any clinically relevant pathology that could interfere with trial results or put subject safety at risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02055469
Study Brief:
Protocol Section:
NCT02055469