SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
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This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.
The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
Enrollment
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Inclusion criteria
- Subject is 18 years of age or older
- Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
- Subject provides informed consent and signs an approved informed consent document for the study
- Subject is willing to comply with the protocol and study visit schedule
Exclusion criteria
- Subject is pregnant or lactating
- Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
- Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
- Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
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Data sourced from clinicaltrials.gov
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