SPY Fluorescence Imaging Systems and Indocyanine Green as a Tool for Developing Intelligent Peri-Operative Imaging

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Cholecystitis
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Brief Title

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

Official Title

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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Outcome 1

Secondary Outcome

 Outcome 2

Condition

Cholecystitis

Intervention

Stryker1688 Fluorescence imaging system

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

50

Start Date

June 28, 2021

Completion Date

September 7, 2022

Primary Completion Date

February 8, 2022

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT05006950

Organization ID

CRD10283

Responsible Party

Sponsor

Study Sponsor

Stryker Endoscopy

Study Sponsor

, ,

Verification Date

September 2022