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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT06119906
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects over 18 years.
* Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm if circumferential (C≥2 according to Prague classification) or 3 cm if not circumferential (maximal extent M≥3, according to Prague classification).
* Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy.
Exclusion Criteria:
* History of oesophageal stricture precluding passage of the endoscope.
* Pregnancy, or planned pregnancy during the course of the study.
* Currently breastfeeding.
* Any history of oesophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B \& C) or evidence of varices on initial treatment endoscopy.
* Any history of oesophageal surgery, except for uncomplicated fundoplication.
* History of coagulopathy, with INR\>1.3 and/or platelet count of \<75,000.
* On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06119906
Study Brief:
Protocol Section:
NCT06119906