Trials / Completed
CompletedNCT03888014
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Cedars-Sinai Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2019-03-25
- Last updated
- 2023-01-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03888014. Inclusion in this directory is not an endorsement.