At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
Fluorescein Sodiumdrug
Likely dose
Fluorescein Sodium 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intraoperative Nerve Identification With Fluorescein Sodium
In Brief
A Phase 2 clinical trial evaluating Fluorescein Sodium for Pleomorphic Adenoma of the Parotid and 5 related conditions. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPleomorphic Adenoma of the Parotid, Warthin Tumor, Head and Neck Disorder, Head and Neck, Thyroid Disease, Thyroidectomy
CountriesUnited States
Timeline
Phase 2CompletedFinished
202420252026
First PostedSep 2023
Enrollment StartNov 2024
Primary CompletionMay 2025
TodayJul 2026
First PostedSep 26, 2023
Enrollment StartNov 7, 2024
Primary CompletionMay 22, 2025
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.8 years ago
Interventions
Fluorescein Sodiumdrug
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg