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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT03685903
Eligibility Criteria:
Inclusion Criteria:
* Males or females at least 18 years of age.
* Provided written HIPAA Informed Consent in the IRB approved language.
* Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
Exclusion Criteria:
* Patients with existing biliary stent will be excluded
* EUS/ERCP exclusion criteria: per medical practice, including:
1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
2. Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
* Capsule Endoscopy (CE) exclusion criteria:
1. CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
2. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03685903
Study Brief:
Protocol Section:
NCT03685903