SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.

Phase 1TerminatedNCT05006950

Stryker Endoscopy50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Cholecystitis

Interventions

Stryker1688 Fluorescence imaging system

The purpose of this study is to use SPY fluorescence imaging systems and indocyanine green (ICG) as a tool to determine the percentage of successful critical anatomy recognition and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Outcome 1

To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy

Time frame: Intra-op visit

Secondary Outcomes

Outcome 2

To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging