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COMPLETED
NCT06227585
PHASE2/PHASE3

Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

Sponsor: Alume Biosciences, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

REVEAL 475 System

The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.

DRUG

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