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

NCT06227585 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-02-25

No results posted yet for this study

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).

Conditions

  • Head and Neck Surgery

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.

Sponsors & Collaborators

  • Alume Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Brett Berman MD FACC, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2025-10-24
Completion
2025-11-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227585 on ClinicalTrials.gov