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

N/ANot Yet RecruitingNCT07523373

Sheba Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Parotid Gland Tumor Facial and Neck Rhytides

Interventions

Non-invasive facial nerve monitoring patchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: During surgery

Secondary Outcomes

Safety of non-invasive patch use

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.

Time frame: During surgery

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

Subjective assessment regarding the usability and integration of the patch during surgery

Time frame: During surgery