Phase 2
Completed N=8
Identification of Nerves Using Fluorescein Sodium
Pleomorphic Adenoma of the Parotid · Warthin Tumor · Head and Neck Disorder · head and neck
Source: ClinicalTrials.gov NCT06054178 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation — 3.8 score on a scale
Summary
The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation |
3.8 | — |
| PRIMARY Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve |
3.7 | — |
| PRIMARY Ratio of Nerve Fluorescence Compared to Background Tissue |
2.5 | — |
| SECONDARY Average Dose of Sodium Fluorescein Administration |
1 | — |
| SECONDARY Time to Nerve Visualization |
151.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects
- 18 years or older
- Scheduled for open head and neck surgery
Exclusion Criteria
- Inability or unwillingness of a subject
- Pregnancy
- Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- History of adverse reaction to fluorescein including allergy.
- History of renal failure or chronic kidney disease
Data sourced from ClinicalTrials.gov (NCT06054178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.