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Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

NCT02070640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-10-21

Study results available
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Summary

The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Conditions

  • Cholecystitis

Interventions

DRUG

Injection of indocyanine green (ICG)

2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.

DEVICE

Near Infrared Cholangiography Fluorescence (NIRF-C)

These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

Sponsors & Collaborators

  • Stryker Instruments

    collaborator INDUSTRY

  • Society of American Gastrointestinal and Endoscopic Surgeons

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Vimal K Narula, MD · Ohio State University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

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 NCT02070640 on ClinicalTrials.gov