A Study to Establish a Registry of Deep Brain Stimulation with the VERCISE™ System
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
- Jacksonville, Florida: 19-002804
Sponsor Protocol Number: A4069
About this study
The purpose of this study is to document characteristics of real-world outcomes for Boston Scientific Corporation’s commercially approved Vercise™ System for Deep Brain Stimulation (DBS) when used according to the applicable Directions for Use.
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:
- Understands the study requirements and the treatment procedures.
- Willing and able to provide written informed consent before any study-specific tests or procedures are performed.
- Plans to receive currently available Vercise™ System and/or any new Commercially Approved components (i.e., leads, extension, Adaptor, CP, etc.) compatible with the Vercise System.
- Meets criteria established in the locally applicable Vercise™ System.
- Directions for Use (DFU) for Parkinson’s disease.
- At least 18 years old.
Exclusion Criteria:
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Ryan Uitti, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available