Parotid Gland DisordersNCT03172520
Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
A study testing APS electrode and Facial Nerve Monitor in people with Parotid Gland Disorders, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Gland Disorders
- What is being tested?
- APS electrode and Facial Nerve Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
Who cannot join
- Current pregnancy
- Preoperative facial nerve dysfunction
- Revision surgery
- History of preoperative radiation to the surgical field
- Retrograde or extracapsular dissection
- Intentional nerve sacrifice (i.e., due to nerve involvement by tumor)
Show all 9Show fewer
- Tumors with proximity to main trunk of facial nerve
- Inability to place electrode
- Presence of electrode alters surgical technique
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.
Read the detailed description
This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.
In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.
- Conditions
- Parotid Gland Disorders
- Being tested
- APS electrode, Facial Nerve Monitor
- Keywords
- Parotidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APS electrodeDevice
Also called automatic periodic stimulating (APS) Electrode Stimulator
The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
Facial Nerve MonitorDevice
Also called NIM-Response 3.0
The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.
| Study group | Role | What they receive |
|---|---|---|
| Facial Nerve Monitoring with APS electrode | Experimental | The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery. Receives: Device: APS electrode; Device: Facial Nerve Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electromyography (EMG)
EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Measured: baseline, approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Dec 2017
Why it stopped: Limitations in timing and personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parotid Gland DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Eric J. Moore, M.D., Mayo Clinic
- Investigators
- Eric J Moore, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172520
- Sponsor's protocol ID
- 16-009380
- Status last verified
- Jan 2020
- First submitted
- 30 May 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
- ClinicalTrials.gov ID
- NCT03172520
- Acronym / sponsor ID
- 16-009380
- Conditions
- Parotid Gland Disorders
- Keywords
- Parotidectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limitations in timing and personnel
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.
Detailed description
This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.
In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Nerve Monitoring with APS electrode | Experimental | Device: APS electrode, Device: Facial Nerve MonitorThe investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
Key exclusion criteria (9 listed)
- Current pregnancy
- Preoperative facial nerve dysfunction
- Revision surgery
- History of preoperative radiation to the surgical field
- Retrograde or extracapsular dissection
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 |
|---|---|---|
| APS electrodeAlso: automatic periodic stimulating (APS) Electrode StimulatorThe APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems. | Device | Facial Nerve Monitoring with APS electrode |
| Facial Nerve MonitorAlso: NIM-Response 3.0The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete. | Device | Facial Nerve Monitoring with APS electrode |
Primary outcome
Change in Electromyography (EMG)
Time frame: baseline, approximately 3 hours
EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eric J Moore principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APS electrode and Facial Nerve Monitor in people with Parotid Gland Disorders, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Electromyography (EMG) (time frame: baseline, approximately 3 hours). 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 18 Jan 2020.