Overview

The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
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. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maimonides Medical Center
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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