Status:
COMPLETED
The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Lead Sponsor:
Maimonides Medical Center
Conditions:
Cholelithiasis
Cholecystitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. Thi...
Detailed Description
The purpose of this study is to evaluate whether systemically injected ICG, when fluorescing in response to NIR illumination, can assist with the identification of the CBD (common bile duct)during lap...
Eligibility Criteria
Inclusion
- Subject is willing and able to provide an informed consent
- Subject is willing and able to comply with the study procedures
- Subject speaks English and is able to understand the study procedures
- A pregnancy test for women of childbearing potential prior to surgery
- Subject is scheduled for laparoscopic cholecystectomy
Exclusion
- Subject has uremia, serum creatinine \>2.5 mg/dl
- Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is a pregnant or lactating female
- Subject is actively participating in another drug, biologic and/or device protocol
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01424215
Start Date
January 1 2011
End Date
August 1 2014
Last Update
May 12 2020
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219