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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02070068
Eligibility Criteria:
Inclusion Criteria:
To be eligible for the study, subjects must fulfill all of the following criteria:
1. Subjects who are healthy men or women 18 years of age or older.
2. Subjects who are scheduled for laparoscopic biliary or hepatic operations.
3. Subjects who sign an approved informed consent form for the study.
4. Subjects who are willing to comply with the protocol.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
1. Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
2. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
3. Subjects who are pregnant or lactating females.
4. Subjects, who are actively participating in another investigational clinical study and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02070068
Study Brief:
Protocol Section:
NCT02070068