A Study to Evaluate a New Device for Increasing Accuracy and Efficiency of Image-Guided Stereo EEG Procedures
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: 15-006273
Sponsor Protocol Number: 15-006273
About this study
The purpose of this study is to evaluate the custom made Stealth Arc Delivery device versus a commercially available device to improve the precision, efficiency and workflow of implanting Stereo electroencephalography (sEEG) electrodes into patients who have medically unmanageable epilepsy. Successful sEEG monitoring can identify areas of the brain where epileptic seizures originate for later surgical removal.
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
- Men and Women
- 18 years of age and older
- Approved for an sEEG procedure by the Epilepsy Conference
- Conference selects patients that would benefit from sEEG monitoring over other monitoring techniques
Exclusion Criteria
- Patients not approved for an sEEG procedure by the Epilepsy Conference
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 W Marsh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available