Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-09 @ 10:56 PM
Study NCT ID:
NCT03172520
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limitations in timing and personnel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: