Parotid Gland TumorNCT07523373
Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch
A study testing Non-invasive facial nerve monitoring patch in people with Parotid Gland Tumor and Facial and Neck Rhytides, run by Sheba Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parotid Gland Tumor, Facial and Neck Rhytides
- What is being tested?
- Non-invasive facial nerve monitoring patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 18 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
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:
Read more
- 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
- Parotid Gland Tumor, Facial and Neck Rhytides
- Being tested
- Non-invasive facial nerve monitoring patch
- Medical subject headings
- Parotid Neoplasms, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual Facial Nerve Monitoring | Experimental | 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. Receives: Device: Non-invasive facial nerve monitoring patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (2)
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.
Measured: 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
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid Gland TumorStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mor Peri Bitterman, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523373
- Sponsor's protocol ID
- SHEBA-26-2695-EA-CTIL
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
- ClinicalTrials.gov ID
- NCT07523373
- Acronym / sponsor ID
- SHEBA-26-2695-EA-CTIL
- Conditions
- Parotid Gland Tumor, Facial and Neck Rhytides
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual Facial Nerve Monitoring | Experimental | Device: Non-invasive facial nerve monitoring patchParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive facial nerve monitoring patchA 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. | Device | Dual Facial Nerve Monitoring |
Primary outcome
Agreement between the patch and the standard monitoring tool in detecting facial nerve activity
Time frame: During surgery
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive facial nerve monitoring patch in people with Parotid Gland Tumor and Facial and Neck Rhytides, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the patch and the standard monitoring tool in detecting facial nerve activity (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.