Clinical trial · Interventional
Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch
A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Facial and Neck Rhytides | — | UNRESOLVED | — |
| Parotid Gland Tumor | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-invasive facial nerve monitoring patch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dual Facial Nerve Monitoring
- description
- 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.
- interventionNames
- Device: Non-invasive facial nerve monitoring patch
Primary outcomes (1)
- measure
- Agreement between the patch and the standard monitoring tool in detecting facial nerve activity
- timeFrame
- During surgery
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available