SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
NCT ID: NCT05006950
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
50 participants
INTERVENTIONAL
2021-06-28
2022-09-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Interventions
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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 Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Stryker Endoscopy
INDUSTRY
Responsible Party
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Locations
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Anne Arundel Medical Center
Annapolis, Maryland, United States
Countries
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Other Identifiers
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CRD10283
Identifier Type: -
Identifier Source: org_study_id
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