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

Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05006950
• Other study ID #: CRD10283
• Status: Terminated
• Phase: Phase 1
• Start date: June 28, 2021
• Est. completion date: September 7, 2022

Study information

• Verified date: September 2022
• Source: Stryker Endoscopy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 7, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Outcome 3	To estimate the number of post-operative complications (related to gall bladder surgery	Post op follow- up (7-14 days)
Primary	Outcome 1	To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy	Intra-op visit
Secondary	Outcome 2	To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging	Intra-op visit