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

NCT04636567 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-07-02

No results posted yet for this study

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).

Conditions

  • Intraoperative Ureter Injury

Interventions

DRUG

Nerindocianine for injection

Procedure: routine minimally invasive abdominopelvic surgery.

Sponsors & Collaborators

  • Li-Cor, Inc.

    lead INDUSTRY

Principal Investigators

  • Giovanna Da Silva Southwich, M.D. · Cleveland Clinic Florida

  • Jubilee Brown, M.D. · Carolinas Medical Center / Levine Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-07-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636567 on ClinicalTrials.gov