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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT01534832
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, at least 18 years of age
2. Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
3. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
Exclusion Criteria:
1. \<18 years of age
2. Pregnant or lactating females
3. Previous extensive abdominal surgery, which in the opinion of the Investigator presents a \>5% risk of conversion to an open procedure being required
4. Current participation in another device or drug study
5. Unwilling or unable to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01534832
Study Brief:
Protocol Section:
NCT01534832