An observational study in Vascular; Lesion, Central Nervous System, Brain Tumor and Cerebral Aneurysm, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Cedars-Sinai Medical Center · Observational
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.
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 7 is below the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used
Exclusion Criteria:
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
Device: GLOW800 · Drug: 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
This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope
Usefulness of Glow800 Technique
Surgeon assessment of Glow800 compared to ICG-VA in usefulness
Time frame: 48 hours
Utility in Identifying a lesion
Surgeon assessment of Glow800 vs ICG-VA in identifying vascular structures (useful, somewhat useful, not useful)
Time frame: 48 hours
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)
Time frame: 48 hours
Additional Cost
Surgeon assessment as to whether there is additional cost at surgery
Time frame: 48 hours
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center