An interventional study of Non-invasive facial nerve monitoring patch in Parotid Gland Tumor and Facial and Neck Rhytides, sponsored by Sheba Medical Center. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Device feasibility
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:
The research team will compare the readings from the patch with those from the standard method used during surgery.
Participants will:
All the decisions during surgery will be based only on the standard method.
27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 18 interventional studies indexed under Parotid Neoplasms.
Browse Parotid Neoplasms studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
No study locations are listed for this record.
Start is estimated for May 2026; primary completion for Feb 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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