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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01770405
Eligibility Criteria:
Inclusion Criteria:
* \- Male or female \> 18 years of age
* Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract
* Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
* Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
* For pancreatic cyst patient, suffering chronic calcifying pancreatitis
* For pancreatic mass patient, any size or location
* For lymph node patient, any node reachable with EUS-FNA
* Willing and able to comply with study procedures and provide written informed consent to participate in the registry
Exclusion Criteria:
* \- Subjects for whom EUS-FNA procedures are contraindicated
* Known allergy to fluorescein contrast
* If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result
* Subject with multiple cysts
* Cysts \<20 mm in diameter
* Previous EUS-FNA procedure performed less than 3 months ago
* If several pancreatic masses, only one will be imaged during the nCLE procedure
* Lymph nodes \<5 mm in diameter
* If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01770405
Study Brief:
Protocol Section:
NCT01770405