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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01439620
Eligibility Criteria:
Inclusion Criteria:
* Patient age ≥18 and up to 75 years old
* Patients able to give informed consent
* Patients with bile duct measuring ≥4 mm in diameter
* Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
* Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure
Exclusion Criteria:
* Patients with pancreatitis
* Pregnant women
* Patients on oral anticoagulant (warfarin) therapy
* Patients with known history of hemostatic disorder
* Patients found to have a biliary fistula on diagnostic ERCP
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01439620
Study Brief:
Protocol Section:
NCT01439620