This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
154
Bevonescein will be infused during the pre-operative period.
Intra-operative real time nerve visualization will be undertaken using WLR with FL Overlay.
Intra-operative real time nerve visualization will be undertaken using WLR.
Alume Biosciences
La Jolla, California, United States
Nerve Conspicuity
Nerve Conspicuity will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System.
Time frame: During surgery
Length Measurement
Nerve Length Measurement in mm will be compared between WLR and WLR with FL Overlay Using a Metric Ruler. Higher values are better than lower values.
Time frame: During Surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.