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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00713427
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Inoperable extrahepatic biliary obstruction by any malignant process
* Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
* Participation in another invesitgational study within 90 days prior to date of patient consent.
* Strictures that cannot be dialated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence of any esophageal or duodenal stent
* Patients for whom endoscopic procedures are contraindicated
* Patients with known senesitivity to any components of the stent or delivery system
* Patients with active hepatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00713427
Study Brief:
Protocol Section:
NCT00713427