Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

NCT03106038 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-11-26

No results posted yet for this study

Summary

The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.

Conditions

  • Intraoperative Ureter Injury

Interventions

DRUG

Nerindocianine for Injection

Procedure: routine minimally invasive pelvic surgery.

Sponsors & Collaborators

  • Li-Cor, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth H. Kim, M.D. · University of Alabama at Birmingham

Study Design

Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2018-11-19
Completion
2018-11-19
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 NCT03106038 on ClinicalTrials.gov