Intraoperative Fluorescence With Augmented Reality

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03888014

Enrollment

Registered

2019-03-25

Start date

2019-07-01

Completion date

2021-06-01

Last updated

2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Cerebral Aneurysm, Cerebral AVM, Vascular; Lesion, Central Nervous System

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.

Interventions

DEVICEGLOW800

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

DRUGindocyanine green (ICG)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Usefulness of Glow800 Technique	48 hours	Surgeon assessment of Glow800 compared to ICG-VA in usefulness

Secondary

Measure	Time frame	Description
Utility in Identifying a lesion	48 hours	Surgeon assessment of Glow800 vs ICG-VA in identifying vascular structures (useful, somewhat useful, not useful)
Surgical workflow	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)
Additional Cost	48 hours	Surgeon assessment as to whether there is additional cost at surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026