A Study of Facial Nerve Monitoring During Surgical Removal of the Parotid Gland for Superficial Benign Lesions
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: 15-000012
Sponsor Protocol Number: 15-000012
About this study
The purpose of this study is to determine the benefit to postoperative facial nerve function of using electromyography (EMG) based monitoring of facial nerve function during surgery to remove the parotid gland for superficial benign lesions.
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
- ≥ 18 years
- Treated at Mayo Clinic for primary, benign parotid lesions using superficial parotidectomy
Exclusion Criteria
- Revision operations
- Prior head and neck radiation
- Prior head and neck surgery
- Malignant parotid lesions
- Patients taking steroids
- Patients with diabetes
- Pregnant patients
- A pregnancy test will be included in the pre-operative workup of all females of childbearing potential enrolled in the study
- Patients with preoperative facial nerve dysfunction
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 Jeffrey Janus, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available