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

A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery

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).

The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.

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.