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Brief Title: ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery
Official Title: ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery
Study ID: NCT05377554
Brief Summary: This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.
Detailed Description: 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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, San Diego, California, United States
Mass Eye and Ear Institute, Boston, Massachusetts, United States
University of New Mexico, Albuquerque, New Mexico, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Name: Ryan Orosco, MD
Affiliation: University of New Mexico
Role: PRINCIPAL_INVESTIGATOR