Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients

Change in Voice Handicap Index (VHI) scores

Mean change in Voice Handicap Index (VHI) scores pre-operatively and post-operatively. Voice Handicap Index (VHI) is a 30-item self-administered questionnaire divided equally into three subscales designed to measure a patient's perceived handicap related to their voice disorder across functional, physical, and emotional domains. Functional (F) subscale (10 items) evaluates how voice problems affect daily activities, work, and social interactions (difficulty being understood on the phone or professional duty limitations). Physical (P) subscale (10 items) addresses physical sensations or characteristics of the voice problem (vocal fatigue, strain, or pitch changes). Emotional (E) subscale (10 items) assesses the emotional impact of a voice disorder (frustration, embarrassment, or anxiety) related to voice use. Item scores range from 0 (never) to 4 (always), with higher scores indicating a greater perceived handicap. Total VHI score: 0 to 120

Time to nerve identification In Thyroid Surgery

Time to nerve identification after the superior pole vessels are taken down, which starts once the superior pole of the thyroid lobe is taken down and stops once the nerve is visualized and confirmed via nerve monitoring device per surgeon preference. In thyroidectomy, the superior pole vessels (typically the superior thyroid artery and its branches) are often dissected and mobilized before proceeding to the superior laryngeal nerve (SLN) identification. The SLN runs in close proximity to the superior thyroid artery, and thus removing the vessel can help expose the nerve and reduce the risk of injury. Earlier identification allows for protection of the nerve before further dissection.

Visualization Scoring System (VSS) scores

Visualization Scoring System (VSS) is completed during the surgery based on the surgeon's visual assessment using the REVEAL 475 system when viewing the surgical field and the recurrent laryngeal nerve. The REVEAL device and supportive illumination system consists of the TriBeam light source (designed to create a 3-inch spot of white or blue light) and filter-modified surgical loupes. The VSS assessment comprises of a 4-point Likert scale for Nerve Conspicuity (NC) and Branching Delineation of the nerve as compared to its surrounding tissue. NC scores: 1- 'None', 2- 'Weak', 3- 'Clear' and 4- 'Clear and Bright'. Branching Delineation scores: 1- 'None', 2- 'Poorly visible', 3- 'Sufficiently visible' Clear' and 4- 'Excellent visibility'. Total scores: 1 to 32. Higher scores mean better visualization.

NERVE Questionnaire for Surgeons

The NERVE questionnaire, consisting of 9 qualitative questions will be completed at the end of the surgical procedure by the surgeon. The questions measure the surgeon's perceived Confidence, Branching (ability to assess the nerve during the procedure), Discrimination (nerve distinction), Trajectory (ability to assess the nerve trajectory), Depth of penetration (ability to assess the nerve as it goes beyond the surgical surface) Convenience, Ease of use (of Bevonescein), Added value (added benefit/value towards nerve identification and/or localization for this patient) and Satisfaction overall. Possible responses to each question: Very satisfied, Satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, Dissatisfied, Very dissatisfied. No numerical scoring scale.