Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
30 participants
INTERVENTIONAL
2024-11-07
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
OTHER
NONE
Study Groups
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Fluorescein sodium during surgery
Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
Fluorescein Sodium
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg
Interventions
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Fluorescein Sodium
Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18 years or older
3. Scheduled for open head and neck surgery
Exclusion Criteria
2. Pregnancy
3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
5. History of adverse reaction to fluorescein including allergy.
6. History of renal failure or chronic kidney disease
18 Years
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Stanford University
OTHER
Responsible Party
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Tulio Valdez
Professor of Otolaryngology
Principal Investigators
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Tulio Valdez, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Medical Center
Palo Alto, California, United States
Countries
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References
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Park RK, Arus BA, Lee JY, Weitzenberg MM, Lee MC, Nyaeme MS, Barthel J, Balsamo G, Baik FM, Speirs K, Blume B, Heller-Algazi M, Chmyrov A, Plettenburg O, Megwalu UC, Weitz J, Distler M, Bruns OT, Valdez TA. Intraoperative nerve imaging with sodium fluorescein. medRxiv [Preprint]. 2025 Feb 17:2025.02.08.25321923. doi: 10.1101/2025.02.08.25321923.
Other Identifiers
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71857
Identifier Type: -
Identifier Source: org_study_id
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