NCT07523373

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

A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parotid Gland Tumor
• Facial and Neck Rhytides

Interventions

Type	Name	Description
DEVICE	Non-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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-02-18
• Completion: 2028-02-18
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated device study