Intraoperative Fluorescence With Augmented Reality

Completed

• Conditions: Brain Tumor; Cerebral Aneurysm; Cerebral AVM; Vascular; Lesion, Central Nervous System
• Interventions: Device: GLOW800; Drug: indocyanine green (ICG)

• Registration Number: NCT03888014
• Lead Sponsor: Cedars-Sinai Medical Center

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 Timeline

• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Study Start: 2019-07-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	GLOW800	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
Treatment group	indocyanine green (ICG)	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

Primary Outcome Measures

Name	Time	Method
Usefulness of Glow800 Technique	48 hours	Surgeon assessment of Glow800 compared to ICG-VA in usefulness

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States