This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488, 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
200
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.
University of California San Diego
La Jolla, California, United States
RECRUITINGContrast Enhancement
Nerve Contrast Enhancement will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System.
Time frame: During surgery
Length Measurement
Nerve Length Measurement will be compared between WLR and WLR with FL Overlay Using a Metric Ruler.
Time frame: During Surgery
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