A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.
The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy or neck dissection surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.
All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.
Jacobs Medical Center at UC San Diego Health
San Diego, California, United States
RECRUITINGSurgeon perspective on REVEAL 475 system blue light illumination
Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome
Time frame: Immediately after surgery
Surgeon perspective on REVEAL 475 system ease of use
Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome
Time frame: Immediately after surgery
Plasma concentration of bevonescein
Measurement of the concentration of bevonescein in plasma from all patients immediately before, during and immediately after surgery.
Time frame: 1.5-5 hours before surgery, during surgery, and 0-12 hours after surgery
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