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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05769257
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects between the ages of 18 and 75, inclusive
2. Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging
Exclusion Criteria:
1. Subject is pregnant or nursing
2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
3. Subject has any of the following screening laboratory values:
1. eGFR \< 60 mL/min/1.73 m\^2
2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
5. 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
6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05769257
Study Brief:
Protocol Section:
NCT05769257