Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery

Withdrawn before enrolling · Phase 2

Conditions studied: Intraoperative Ureter Injury

In brief

Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).

Key facts

Study ID

NCT04636567

Run by

Li-Cor, Inc.

People needed

0

Starts

2021-03-01

Expected to finish

2021-12-01

Last updated by the study team

2021-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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