Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive facial nerve monitoring patch.
- Who it may be relevant to
- Registry conditions: Parotid Gland Tumor, Facial and Neck Rhytides. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
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.
Interventions
- 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.
Primary outcome measures
- Agreement between the patch and the standard monitoring tool in detecting facial nerve activity [Time frame: During surgery]
Secondary outcome measures (2)
- Safety of non-invasive patch use [Time frame: During surgery]
- Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring [Time frame: During surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07523373 · SHEBA-26-2695-EA-CTIL