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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01862666
Eligibility Criteria:
Inclusion Criteria:
* Males and females over the age of 18 years.
* Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
\- Only en-bloc resections will be investigated, requiring lesions with a maximum diameter of 15 mm with a Paris classification of 0-IIa, b, c, or a combination.
* Ability to provide written, informed consent.
* Women of childbearing potential must be willing to take a pregnancy test.
Exclusion Criteria:
* Patients on anticoagulation.
* Patients with esophageal varices that preclude either mucosal resection or biopsies.
* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
* Patients with known eosinophilic esophagitis.
* Patients that are pregnant.
* Patients with a history of hemostasis disorders\*.
* Patients with esophagitis above grade A.
* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01862666
Study Brief:
Protocol Section:
NCT01862666