Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSheba Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non-invasive facial nerve monitoring patch
DeviceA 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Dual Facial Nerve MonitoringExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
During surgerySecondary outcomes
1
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 surgery2
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 surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: