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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT01424293
Eligibility Criteria:
Inclusion Criteria:
* Candidates for this study must meet ALL of the following inclusion criteria:
* Subject is willing and able to provide an informed consent
* Subject is willing and able to comply with the study procedures
* Subject speaks English and is able to understand the study procedures
* A pregnancy test for women of childbearing potential prior to surgery
* Subject is scheduled for laparoscopic low anterior resection
Exclusion Criteria:
* Candidates for this study who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
* Subject has uremia, serum creatinine \>2.5 mg/dl
* Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
* Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is a pregnant or lactating female
* Subject is actively participating in another drug, biologic and/or device protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01424293
Study Brief:
Protocol Section:
NCT01424293