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Trial Outcomes & Findings for Identification of Nerves Using Fluorescein Sodium (NCT NCT06054178)

NCT ID: NCT06054178

Last Updated: 2026-05-20

Results Overview

Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Intraoperative (day 1, up to 1 minute to assess)

Results posted on

2026-05-20

Participant Flow

Participant milestones

Participant milestones
Measure
Fluorescein Sodium During Surgery
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Identification of Nerves Using Fluorescein Sodium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Age, Continuous
49.9 years
STANDARD_DEVIATION 20.3 • n=30 Participants
Sex: Female, Male
Female
4 Participants
n=30 Participants
Sex: Female, Male
Male
4 Participants
n=30 Participants
Race/Ethnicity, Customized
White
4 Participants
n=30 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=30 Participants
Race/Ethnicity, Customized
Non-white hispanic
1 Participants
n=30 Participants
Region of Enrollment
United States
8 Participants
n=30 Participants

PRIMARY outcome

Timeframe: Intraoperative (day 1, up to 1 minute to assess)

Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation

Outcome measures

Outcome measures
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation
3.8 score on a scale
Standard Deviation 0.4

PRIMARY outcome

Timeframe: Intraoperative (day 1, up to 1 minute to assess)

Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Outcome measures

Outcome measures
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve
3.7 score on a scale
Standard Deviation 0.5

PRIMARY outcome

Timeframe: Intraoperative (Day 1, Up to 20 minutes to assess)

Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity

Outcome measures

Outcome measures
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Ratio of Nerve Fluorescence Compared to Background Tissue
2.5 Ratio
Standard Deviation 1

SECONDARY outcome

Timeframe: Intraoperative (day 1)

Average dose of sodium fluorescein administered in mg/kg

Outcome measures

Outcome measures
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Average Dose of Sodium Fluorescein Administration
1 mg/kg
Standard Deviation 0

SECONDARY outcome

Timeframe: Intraoperative (day 1, up to approximately 200 minutes for initial imaging)

Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration

Outcome measures

Outcome measures
Measure
Fluorescein Sodium During Surgery
n=8 Participants
Subjects undergoing head and neck surgery have fluorescein sodium administered intravenously after induction
Time to Nerve Visualization
151.4 minutes
Standard Deviation 26.9

Adverse Events

Fluorescein Sodium During Surgery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tulio Valdez, MD

Stanford University

Phone: 650-724-4800

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place