Identification of Nerves Using Fluorescein Sodium (NCT06054178) | Clinical Trial Compass
CompletedPhase 2
Identification of Nerves Using Fluorescein Sodium
United States8 participantsStarted 2024-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used fluorescein sodium to try to light up nerves like the facial nerve during parotid surgery — since the trial is now completed, has any of its data been published, and what did it suggest about whether this technique actually helped surgeons identify nerves more reliably?
2Since the trial compared fluorescein sodium's glow against electrostimulation and the surgeon's own visual judgment, can you explain how the nerve identification approach you currently use in my surgery compares to what this trial was testing?
3The facial nerve is a major concern during parotid gland surgery for conditions like pleomorphic adenoma or Warthin tumor — if this fluorescein technique isn't yet standard practice, what is your current method for protecting the facial nerve, and how does that affect my risk of facial weakness or paralysis?
4This was a Phase 2 trial, which means it was still in an early stage of testing safety and effectiveness — does that mean fluorescein-assisted nerve identification is not yet proven enough to be used in routine surgery, and should I be asking about trials or centers where it might still be available?
5For someone facing thyroid surgery or parotid surgery, would it be worth seeking out a surgeon or center that participated in this trial or is continuing this type of research, given that nerve preservation is such a critical part of my procedure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation
Timeframe: Intraoperative (day 1, up to 1 minute to assess)
2
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve
Timeframe: Intraoperative (day 1, up to 1 minute to assess)
3
Ratio of Nerve Fluorescence Compared to Background Tissue
Timeframe: Intraoperative (Day 1, Up to 20 minutes to assess)