Facial and Neck Rhytides, Parotid Gland Tumor
Conditions
Brief summary
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.
Interventions
DEVICENon-invasive facial nerve monitoring patch
A non-invasive surface electrode patch applied to the face to continuously monitor facial nerve activity during surgery. The patch uses dry electrodes to detect electrical signals associated with nerve stimulation and muscle activity. Data are recorded throughout the procedure for analysis. The patch operates in parallel with the standard monitoring method and does not influence clinical decision making.
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between the patch and the standard monitoring tool in detecting facial nerve activity | During surgery | Agreement between the non-invasive patch and the standard monitoring method in detecting facial nerve activity during surgery. Agreement evaluation will be based on concordance in detection and temporal correlation of nerve responses recorded by both methods during intraoperative stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of non-invasive patch use | During surgery | Evaluation of device-related adverse effects associated with the use of the non-invasive facial nerve monitoring patch during surgery, including skin reactions or other local adverse effects. |
| Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring | During surgery | Subjective assessment regarding the usability and integration of the patch during surgery |
Outcome results
None listed