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

NCT05006950 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-09-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Stryker Endoscopy

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2022-02-08
Completion
2022-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05006950 on ClinicalTrials.gov