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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01343160
Eligibility Criteria:
Inclusion Criteria:
* Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
* Subject is ≥18 years of age
* Subject is able to comply with study protocol and follow-up requirements
* Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form
Exclusion Criteria:
* Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
* Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
* The subject has malignant biliary disease
* Subject has known pregnancy
* Participated in protocol involving investigational drug or device within 90 days prior to entry into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01343160
Study Brief:
Protocol Section:
NCT01343160