The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Completed · Not applicable
Conditions studied: Cholelithiasis, Cholecystitis, Pancreatitis Biliary, Colic of Gallbladder Without Mention of Cholecystitis
In brief
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. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.
Key facts
- Study ID
- NCT01424215
- Run by
- Maimonides Medical Center
- People needed
- 100
- Starts
- 2011-01-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2020-05-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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