Intraoperative Fluorescence With Augmented Reality

Cedars-Sinai Medical Center

Status: Completed

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

Treatments: Drug: indocyanine green (ICG); Device: GLOW800

Study type: Observational

Funder types: Other

Identifiers

NCT03888014

Pro00051776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

7 participants in 1 patient group

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

Treatment:

Device: GLOW800

Drug: indocyanine green (ICG)