A Study to Determine the Long-Term Real-World Outcomes on Patients Implanted With a Neurostimulator
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: 20-007049
NCT ID: NCT03876054
Sponsor Protocol Number: ABT-CIP-10279
About this study
The study is being conducted to gain a broader understanding of how Abbott’s neurostimulation systems are being used in the real-world setting. It will serve the dual purpose of collecting long-term safety and effectiveness of these devices and obtaining information about the different patient populations who are using them.
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 must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
- Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
Exclusion Criteria:
- Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements.
- Subject has or is scheduled to receive an intrathecal pump.
- Subject is part of a vulnerable population.
- Subject has an existing implanted neuromodulation device to address their chronic pain.
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 Oludare Olatoye, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available