Clinical trial · Observational
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
NCT03888014CI-TRIAL-00063296completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Cerebral Aneurysm | — | UNRESOLVED | — |
| Cerebral AVM | — | UNRESOLVED | — |
| Vascular; Lesion, Central Nervous System | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GLOW800 | Device | — | UNRESOLVED |
| indocyanine green (ICG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Device: GLOW800
- Drug: indocyanine green (ICG)
Primary outcomes (1)
- measure
- Usefulness of Glow800 Technique
- timeFrame
- 48 hours
- description
- Surgeon assessment of Glow800 compared to ICG-VA in usefulness
Secondary outcomes (3)
- measure
- Utility in Identifying a lesion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.