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COMPLETED
NCT05377554
PHASE3

Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery

Sponsor: Alume Biosciences, Inc.

View on ClinicalTrials.gov

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

DRUG

Bevonescein

Bevonescein will be infused during the pre-operative period.

OTHER

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.

OTHER

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