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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07368335
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 to 80 years, inclusive.
2. Diagnosed with common bile duct stones based on symptoms, signs, laboratory tests, and imaging examinations, and deemed suitable by the investigator for endoscopic common bile duct stone removal (lithotomy).
3. Willing to comply with all study procedures; able to understand the study purpose, and voluntarily provide written informed consent.
Exclusion Criteria:
1. Severe cardiac, pulmonary, renal, or hepatic insufficiency, or mental disorders.
2. Active viral hepatitis.
3. Upper gastrointestinal stenosis, obstruction, or any condition preventing endoscopic access to the descending duodenum.
4. Known intolerance to anesthetics or hypersensitivity to contrast agents.
5. Non-lithogenic obstructive acute pancreatitis or acute exacerbation of chronic pancreatitis.
6. Pregnant or lactating women.
7. Active peptic ulcer or upper gastrointestinal hemorrhage within one month prior to informed consent.
8. Known severe bleeding tendency (coagulopathy).
9. History of upper gastrointestinal reconstruction surgery resulting in altered anatomy.
10. Previous endoscopic sphincterotomy of the duodenal papilla.
11. Inability to cooperate with ERCP procedures.
12. Participation in a drug clinical trial within the past 3 months, or in another medical device clinical trial (excluding non-interventional studies) within the past month.
13. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for the trial (including but not limited to duodenal mucosal edema, papillary malformation, papillary surface ulcer, papillary fistula, or difficult-to-treat stones).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07368335
Study Brief:
Protocol Section:
NCT07368335