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

NCT07523373 | Not Yet Recruiting FDA Device

• 1 other identifier: SHEBA-26-2695-EA-CTIL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parotid Gland Tumor; Facial and Neck Rhytides

Outcome Measures

Primary Outcomes (1)

• Agreement between the patch and the standard monitoring tool in detecting facial nerve activity

  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.

  During surgery

Secondary Outcomes (2)

• Safety of non-invasive patch use

  During surgery

• Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring

  During surgery

Study Arms (1)

Dual Facial Nerve Monitoring

EXPERIMENTAL

Participants will undergo intraoperative facial nerve monitoring using the standard monitoring method along with a non-invasive patch applied to the face. Both methods will be used during the same surgery for all participants, and clinical decisions will be based solely on the standard monitoring method.

Device: Non-invasive facial nerve monitoring patch

Interventions

Non-invasive facial nerve monitoring patch DEVICE

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.

Dual Facial Nerve Monitoring

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Parotid Neoplasms; Facies

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): February 18, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04