Intraoperative Fluorescence With Augmented Reality

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888014
• Other study ID #: Pro00051776
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• 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

Drug:
• indocyanine green (ICG)
This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usefulness of Glow800 Technique	Surgeon assessment of Glow800 compared to ICG-VA in usefulness	48 hours
Secondary	Utility in Identifying a lesion	Surgeon assessment of Glow800 vs ICG-VA in identifying vascular structures (useful, somewhat useful, not useful)	48 hours
Secondary	Surgical workflow	Surgeon assessment of whether there is additional time (no additional time, <15 minutes additional time, <30 minutes additional time, >30 minutes additional time)	48 hours
Secondary	Additional Cost	Surgeon assessment as to whether there is additional cost at surgery	48 hours