A Study to Evaluate The Use of Intravenous Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery for Vestibular Schwannomas (VS)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-005178
NCT ID: NCT04351373
Sponsor Protocol Number: 19-005178
About this study
The purpose of this study is to evaluate the benefit of using intravenous fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery for vestibular schwannomas (VS), Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma and to determine the optimum FS dose and timing to be used with the YE560 device.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Patients 18 years and older.
- Patient with a suspected Vestibular Schwannoma (VS).
- Recurrent VS with prior microsurgical resection or radiation therapy.
- Clinical indication for microsurgical resection.
- Children (patients less than 18 years of age).
- History of allergy to Fluorescein Sodium (FS).
- History of renal failure.
- Pregnant women.
- Those with inability to give informed consent or the legally authorized representative is unable to give informed consent.
- Prisoners and inmates.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Matthew Carlson, M.D.
Closed for enrollment
Publications are currently not available