Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSheba Medical Center

About this trial

The goal of this study is to test if a non-invasive patch can safely monitor facial nerve activity in adults during parotid or facial surgery. Monitoring the facial nerve during these surgeries helps lower the risk of nerve injury and possible functional and aesthetic damage. Current methods use small needles and require careful placement, which can be difficult and may affect how well they work.

The aims to answer the following questions:

* Can the patch provide similar results to the standard monitoring method? * Is the patch safe and easy to use during surgery?

The research team will compare the readings from the patch with those from the standard method used during surgery.

Participants will:

* Undergo their planned surgery as usual * Have a patch placed on the face before the surgery * Have both the standard method and the patch monitor the facial nerve during surgery * Have the data extracted from the monitoring tools and analyzed without personal identifying information.

All the decisions during surgery will be based only on the standard method.

Eligibility criteria

Qualifiers

Age 18 to 99 years

Hebrew speakers

Ability to understand the study requirements and provide informed consent

Ability to cooperate with the research team throughout the study procedures

Disqualifiers

Current or past comorbidity affecting facial nerve function

Previous injection of botulinum toxin to the face

Skin conditions that may interfere with the placement or function of the investigational patch, according to the manufacturer's guidelines

Known allergy to any component of the dry electrode patch

Trial design

Treatments tested in this trial

  • Non-invasive facial nerve monitoring patch

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators