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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02018367
Eligibility Criteria:
Inclusion Criteria:
* outpatients with \> 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.
Exclusion Criteria:
* Allergy or prior reaction to the fluorescent contrast agent proflavine
* Patients who are unable to give informed consent.
* Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion \> 2 cm in size not amenable to EMR
* Patients with a history of a severe allergic reaction (anaphylaxis)
* Patients unable to undergo routine endoscopy with biopsy :
* Women who are pregnant or breastfeeding
* Prothrombin Time \> 50% of control; PTT \> 50 sec, or INR \> 2.0)
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
* Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
* Patients with known severe esophagitis
* Patients with suspected but no biopsy confirmed BE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02018367
Study Brief:
Protocol Section:
NCT02018367