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

Phase 2/3 Completed 155 enrolled Alume Biosciences, Inc.

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2023-11-29
Primary completion: 2025-10-24
Completion: 2025-11-24

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevonescein	Peptide	500 mg	Intravenous

Indications

No indication recorded.