NCT05377554

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

Bevonescein (ALM-488) For Intra-Operative Visualization of Nerves In Head And Neck Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Alume Biosciences, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.

Detailed description

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein, a visualization adjunct for the real-time enhanced structural delineation of major nerves, in patients undergoing surgery of the Head and Neck.

Conditions

• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-29
• Primary completion: 2025-10-27
• Completion: 2025-11-24
• First posted: 2022-05-17
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study