Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy

NCT03172520 | Terminated Results FDA Device

• 1 other identifier: 16-009380
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parotid Gland Disorders

Keywords

Parotidectomy

Outcome Measures

Primary Outcomes (1)

• Change in Electromyography (EMG)

  EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

  baseline, approximately 3 hours

Study Arms (1)

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.

Device: APS electrode; Device: Facial Nerve Monitor

Interventions

APS electrode DEVICE

The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Also known as: automatic periodic stimulating (APS) Electrode Stimulator

Facial Nerve Monitoring with APS electrode

Facial Nerve Monitor DEVICE

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.

Also known as: NIM-Response 3.0

Facial Nerve Monitoring with APS electrode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
• Benign or malignant disease

You may not qualify if:

• 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)
• Tumors with proximity to main trunk of facial nerve
• Inability to place electrode
• Presence of electrode alters surgical technique

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Eric J. Moore, M.D.
• Organization: Mayo Clinic

Moore.Eric@mayo.edu

507-284-3853

Study Officials

• Eric J Moore

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: December 30, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)