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Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery
Sponsor: Alume Biosciences, Inc.
Summary
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
Official title: Bevonescein (ALM-488) For Intra-Operative Visualization of Nerves In Head And Neck Surgery
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2022-04-29
Completion Date
2025-11-24
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Bevonescein
Bevonescein will be infused during the pre-operative period.
Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay
Intra-operative real time nerve visualization will be undertaken using WLR with FL Overlay.
Intra-operative Visualization using White Light Reflectance (WLR)
Intra-operative real time nerve visualization will be undertaken using WLR.
Locations (1)
Alume Biosciences
La Jolla, California, United States