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

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Brief Title

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

Official Title

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study

Brief 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Adverse events related to use of indocyanine green (ICG)

Condition

Acute Cholecystitis

Intervention

Indocyanine Green (ICG)

Study Arms / Comparison Groups

 NIRF-C and IOC
Description:  Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

6

Start Date

July 2013

Completion Date

August 2014

Primary Completion Date

August 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18-89

          -  Planned laparoscopic cholecystectomy

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Pregnant

          -  Allergy to ICG, iodine, and/or shellfish

          -  Lactating

Gender

All

Ages

18 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

Vimal K Narula, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02070627

Organization ID

2011H0239S

Responsible Party

Principal Investigator

Study Sponsor

Ohio State University

Collaborators

 Stryker Instruments

Study Sponsor

Vimal K Narula, MD, Principal Investigator, Ohio State University

Verification Date

October 2014