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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Intraoperative Ureter Injury

Intervention / Treatment
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* Drug: Nerindocianine for injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerindocianine for injection<br>One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery. | Drug: Nerindocianine for injection<br>* Procedure: routine minimally invasive abdominopelvic surgery.<br>* Other names: IRDye 800BK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ureter delineation using a Likert scale to measure ureter visualization | Evaluation of the pelvic ureter under WL and NIR illumination | Surgical procedure duration, estimated up to 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events | 30 +/- 5 days | 
| Hourly time point scores concurrence with video review | Three 3-pt Likert scale scores at hourly time points during the procedure. | Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast agent, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive