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Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study

NCT02070627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-11-03

No results posted yet for this study

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) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Conditions

  • Acute Cholecystitis
  • Acute Cholangitis

Interventions

DRUG

Indocyanine Green (ICG)

60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.

DEVICE

Near Infrared Fluorescence Cholangiography (NIRF-C)

Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.

Sponsors & Collaborators

  • Stryker Instruments

    collaborator INDUSTRY

  • 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
2013-07-31
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 NCT02070627 on ClinicalTrials.gov