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

NCT05006950 | Terminated Phase 1 FDA Device

• 1 other identifier: CRD10283
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Outcome 2

  Intra-op visit

Other Outcomes (1)

• Outcome 3

  Post op follow- up (7-14 days)

Interventions

Stryker1688 Fluorescence imaging system DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Endoscopy: lead

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: June 28, 2021
• Primary Completion: February 8, 2022
• Study Completion: September 7, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)