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Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery
Sponsor: Alume Biosciences, Inc.
Summary
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use. A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring System (VSS).
Official title: Phase 2/3 Safety and Efficacy Trial of the REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2023-11-29
Completion Date
2026-01-05
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
REVEAL 475 System
The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.
Bevonescein
All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.
Locations (1)
Alume Biosciences
La Jolla, California, United States