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

Intraoperative Ureter Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04636567
• Other study ID #: LICOR-10417-04
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2021
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Li-Cor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraoperative Ureter Injury

Intervention

Drug:
• Nerindocianine for injection
Procedure: routine minimally invasive abdominopelvic surgery.

Locations

Country	Name	City	State
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Li-Cor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events	30 +/- 5 days
Secondary	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)