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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT07120295
Eligibility Criteria:
Inclusion Criteria:
1. Provision to sign and date the consent form;
2. Adult patients ≥ 21 years old;
3. Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
1. Indeterminate biliary stricture, or
2. Failed biliary stone extraction with conventional techniques.
4. Willing and able to follow study procedures and comply with study follow-up.
Exclusion Criteria:
1. Pregnancy or lactation;
2. Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
3. Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
4. Coagulopathy (INR \> 1.8) or thrombocytopenia (Platelets \< 50,000) that is not correctable and felt to be a contraindication to proceeding with biopsy or lithotripsy per the treating endoscopist;
5. Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
6. Patients who are not candidates for anesthesia to permit ERCP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07120295
Study Brief:
Protocol Section:
NCT07120295