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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05954767
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria
1. Female subject is between the ages of 18 and 75, inclusive.
2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.
3. Subject is willing and able to provide informed consent.
Exclusion Criteria:
1. Subject is pregnant or nursing.
2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
4. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.
5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
6. Subject has any of the following screening laboratory values:
1. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2
2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)
3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05954767
Study Brief:
Protocol Section:
NCT05954767