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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT04293458
Eligibility Criteria:
Inclusion Criteria:
1. Men aged 50 years old and older
2. ≥5 years either of
* GERD symptoms,
* GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
* any combination of treated and untreated periods, as long the cumulative total is at least 5 years
3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
4. One or more of the following risk factors:
1. Caucasian race
2. Current or past history of cigarette smoking
3. BMI of at least 30 kg/m2
4. First-degree relative with BE or EAC
\-
Exclusion Criteria:
1. History of prior EGD procedure
2. Inability to provide written informed consent
3. On anti-coagulant drug(s) that cannot be temporarily discontinued
4. Known history of esophageal varices or esophageal stricture
5. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
7. Oropharyngeal tumor
8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
9. History of myocardial infarction or cerebrovascular accident within past 6 months
10. History of esophageal motility disorder
11. Currently implanted Linx device
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT04293458
Study Brief:
Protocol Section:
NCT04293458