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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT04636567
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent prior to the initiation of study procedures.
* At least 18 years of age.
* Consent to undergo minimally invasive, lower pelvic surgery.
Exclusion Criteria:
* Unwilling or unable to provide informed consent.
* Unwilling or unable to comply with the requirements of the protocol.
* Females who are pregnant, lactating, or planning a pregnancy throughout the study.
* Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.
* Have known allergies to D-mannitol and/or citric acid.
* Participation in another clinical trial involving a drug in the past 12 weeks.
* Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04636567
Study Brief:
Protocol Section:
NCT04636567