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

Phase 1

Terminated

• Conditions: Cholecystitis

• Registration Number: NCT05006950
• Lead Sponsor: Stryker Endoscopy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-28
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-16
• Primary Completion: 2022-02-08
• Status Verified: 2022-09
• Study Completion: 2022-09-07
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Outcome 1	Intra-op visit	To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Outcome 2	Intra-op visit	To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging

Trial Locations

Locations (1)

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States