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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT07036432
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a histopathologically confirmed diagnosis of Barrett's esophagus, specifically showing intestinal metaplasia.
* Patients must have at least a C0M1 Prague classification for their Barrett's esophagus.
* Patients must be under active monitoring with a surveillance endoscopy already planned to occur within the next 3 to 12 months.
* Patients must be between 18 and 84 years of age.
Exclusion Criteria:
* Patients scheduled for any endoscopic treatment (such as ablation) during their upcoming surveillance endoscopy.
* Patients experiencing alarm symptoms, including:
* Dysphagia (difficulty swallowing) and/or food sticking.
* Dyspepsia (indigestion) combined with weight loss.
* Dyspepsia combined with anaemia.
* Patients with a current diagnosis of an oropharyngeal, esophageal, or gastro-oesophageal tumour.
* Patients who have received treatment to their esophagus (e.g., endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), radiofrequency ablation (RFA), or surgery) within the last two months.
* Patients known to have gastric or oesophageal varices or cirrhosis of the liver.
* Patients with any known anomaly of the oesophagus, such as webbing, pouches, or strictures.
* Patients who are unable to provide informed consent.
* Patients who have had a stroke or possess any other neurological disorder that has affected their swallowing ability.
* Patients who have experienced a myocardial infarction (heart attack) within the past 3 months.
* Patients who have undergone fundoplication or any other surgery involving the esophagus and proximal (upper) stomach.
* Patients currently using anti-trombotic medications which cannot be safely stopped temporarily for the procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT07036432
Study Brief:
Protocol Section:
NCT07036432