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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-12-31

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).

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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.

Conditions

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Intraoperative Ureter Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nerindocianine for injection

One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery.

Group Type EXPERIMENTAL

Nerindocianine for injection

Intervention Type DRUG

Procedure: routine minimally invasive abdominopelvic surgery.

Interventions

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Nerindocianine for injection

Procedure: routine minimally invasive abdominopelvic surgery.

Intervention Type DRUG

Other Intervention Names

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IRDye 800BK

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No