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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT01818050
Eligibility Criteria:
Inclusion Criteria:
* All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
* Expected patient survival of at least 90 days
* High likelihood of patient follow-up
* Patient is able to give a written informed consent
* Patient is willing and able to comply with the study procedures.
Exclusion Criteria:
* Patients with cholangitis
* Patients with bile leak
* Pregnant patients
* Patients with any contraindication to endoscopic procedure
* Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
* Patients with malignant biliary strictures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01818050
Study Brief:
Protocol Section:
NCT01818050