NCT06227585

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Alume Biosciences, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part 1 Phase 2: All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. Part 2 Phase 3: All patients receive a single dose of bevonescein 500mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. During the surgery the REVEAL 475 system will be used to assess through the use of the Visualization Scoring System (VSS).

Conditions

• Head and Neck Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-29
• Primary completion: 2025-10-24
• Completion: 2025-11-24
• First posted: 2024-01-29
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study