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OpenTrials
Completed

NCT Number: NCT03888014

Intraoperative Fluorescence With Augmented Reality

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.

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Key information

Conditions

Vascular; Lesion, Central Nervous System Aneurysm Arteriovenous Malformations Brain Diseases Brain Neoplasms Brain Tumor Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Central Nervous System Vascular Malformations Cerebral AVM Cerebral Aneurysm Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GLOW800

Device

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

Indocyanine Green (ICG)

Drug

This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope

Primary outcomes

  1. Usefulness of Glow800 Technique

    Time frame: 48 hours

    Surgeon assessment of Glow800 compared to ICG-VA in usefulness

Secondary outcomes

  1. Utility in Identifying a lesion

    Time frame: 48 hours

    Surgeon assessment of Glow800 vs ICG-VA in identifying vascular structures (useful, somewhat useful, not useful)

  2. Surgical workflow

    Time frame: 48 hours

    Surgeon assessment of whether there is additional time (no additional time, <15 minutes additional time, <30 minutes additional time, >30 minutes additional time)

  3. Additional Cost

    Time frame: 48 hours

    Surgeon assessment as to whether there is additional cost at surgery

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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