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