Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009380
NCT ID: NCT03172520
Sponsor Protocol Number: 16-009380
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
Exclusion Criteria:
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Eric Moore, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available