Bevonescein for Nerve Visualization in Head and Neck Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a special tool called the REVEAL 475 system that helps surgeons see nerves better during certain neck surgeries. Patients will receive a dye called bevonescein that makes their nerves glow under this tool. This can help surgeons avoid damaging important nerves.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team or your doctor for guidance.
Is Bevonescein safe for use in humans?
How is the REVEAL 475 System treatment different from other treatments for nerve visualization in head and neck surgery?
The REVEAL 475 System is unique because it uses a fluorescent labeling technique to enhance the visibility of nerves during surgery, which can help prevent accidental nerve damage. This system provides real-time visualization of nerves, even those buried beneath tissue, which is not possible with traditional white light imaging.12356
What data supports the effectiveness of the treatment Bevonescein for nerve visualization in head and neck surgery?
Research on similar treatments shows that using near-infrared (NIR) fluorophores can help surgeons see nerves more clearly during surgery, reducing the risk of accidental nerve damage. Studies have demonstrated that these fluorophores improve nerve visibility, even when nerves are hidden under tissue, which could lead to better surgical outcomes.12456
Who Is on the Research Team?
Brett Berman, MD
Principal Investigator
Chief Medical Officer
Are You a Good Fit for This Trial?
This trial is for patients undergoing head and neck surgery who may benefit from enhanced nerve visualization. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedure and the investigational imaging system.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Preparation
Participants receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery
Surgery
The REVEAL 475 system is used for nerve visualization during parotidectomy, thyroidectomy, or neck dissection surgery
Follow-up
Participants are monitored for plasma concentration of bevonescein and surgeon feedback is collected
What Are the Treatments Tested in This Trial?
Interventions
- Bevonescein
- REVEAL 475 System
REVEAL 475 System is already approved in United States for the following indications:
- Nerve visualization during head and neck surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alume Biosciences, Inc.
Lead Sponsor
Ergomed
Industry Sponsor