NCT03888014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

February 22, 2019

Last Update Submit

January 16, 2023

Conditions

Vascular; Lesion, Central Nervous SystemBrain TumorCerebral AneurysmCerebral AVM

Outcome Measures

Primary Outcomes (1)

  • Usefulness of Glow800 Technique

    Surgeon assessment of Glow800 compared to ICG-VA in usefulness

    48 hours

Secondary Outcomes (3)

  • Utility in Identifying a lesion

    48 hours

  • Surgical workflow

    48 hours

  • Additional Cost

    48 hours

Study Arms (1)

Treatment group

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: GLOW800Drug: indocyanine green (ICG)

Interventions

GLOW800DEVICE

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 group
indocyanine green (ICG)DRUG

This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used

You may qualify if:

  • adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used

You may not qualify if:

  • allergy to ICG (indocyanine green)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsIntracranial AneurysmIntracranial Arteriovenous Malformations

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersAneurysmVascular DiseasesCardiovascular DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 25, 2019

Study Start

July 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

US(1)