Clinical Evaluation of the Infinity DBS System
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 16-010295
NCT ID: NCT02989610
Sponsor Protocol Number: SJM-CIP-10061
About this study
The purpose of this post market study is to support the chronic clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads, extensions and related system components.
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:
- Subject is able to provide informed consent;
- Subjects diagnosed with Parkinson's disease (PD) and have been recommended to receive a DBS implant in the Subthalamic Nucleus (STN) or that have been implanted with an Infinity system in the STN;
- Subject must be available for follow-up visits.
Exclusion Criteria:
- Subject is not a surgical candidate;
- In the Investigator's opinion the subject is unable to tolerate multiple programming sessions within a single setting;
- Subject is unable to comply with the follow up schedule.
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