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).
Part 1 Phase 2: All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. Part 2 Phase 3: All patients receive a single dose of bevonescein 500mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. During the surgery the REVEAL 475 system will be used to assess through the use of the Visualization Scoring System (VSS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
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.
Alume Biosciences
La Jolla, California, United States
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system blue light illumination
Surgeon assessment to questions
Time frame: Immediately after surgery
Part 1 Phase 2 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
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Nerve Conspicuity
Mean NC score assessed by the surgeon for all applicable index nerves per patient
Time frame: During Surgery
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Length Measurement of nerves that can be visualized
Mean LM score assessed by the surgeon for all applicable index nerves per patient
Time frame: During Surgery
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