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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT01563133
Eligibility Criteria:
Inclusion Criteria:
* Male or female \> 18 years of age.
* Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
* Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
* Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
* Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Add for lymph nodes:
\- any lymph node reachable with EUS-FNA
Add for pancreatic mass:
* any size
* any location in the pancreas
Exclusion Criteria:
* Subjects for whom EUS-FNA procedures are contraindicated
* Known allergy to fluorescein dye
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Add for cysts:
* Subject with multiple cysts
* size \< 20mm in diameter
* previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis
Add for lymph nodes:
* size \< 5mm in diameter
* If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure
Add for pancreatic mass:
\- If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01563133
Study Brief:
Protocol Section:
NCT01563133