Intraoperative Fluorescence With Augmented Reality

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Brief Title

Intraoperative Fluorescence With Augmented Reality

Official Title

Phase 4 Open Label Study Of Indocyanine Green Video Angiography (ICG-VA) And Comparative Utility Of Glow800 And FL800 Intraoperative ICG-VA Tools For Intracranial Lesions

Brief Summary

      This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery
      patients using a standard & approved intravenous dye and augmented reality.
    

Detailed Description

      This is a study investigating a new technique with an approved medication (ICG or indocyanine
      green) and using that and a near infrared mode on a standard operating room microscope to see
      the information provided for vascular or neoplastic (tumor related) neurosurgical problems.
      The technique uses the data from the microscope and using ICG with augmented reality
      overlaying the data into the microscope view (this is the new process). The technique is
      called GLOW800.
    


Study Type

Observational


Primary Outcome

Usefulness of Glow800 Technique

Secondary Outcome

 Utility in Identifying a lesion

Condition

Vascular; Lesion, Central Nervous System

Intervention

GLOW800

Study Arms / Comparison Groups

 Treatment group
Description:  The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery

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

20

Start Date

March 2019

Completion Date

March 2020

Primary Completion Date

March 2020

Eligibility Criteria

        Inclusion Criteria:

          -  adult patients with a brain lesion requiring surgery and for whom ICG videoangiography
             would be used

        Exclusion Criteria:

          -  allergy to ICG (indocyanine green)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 3102486693, [email protected]



Administrative Informations


NCT ID

NCT03888014

Organization ID

Pro00051776


Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center


Study Sponsor

, , 


Verification Date

March 2019