A Study to Determine the Long-Term Real-World Outcomes on Patients Implanted With a Neurostimulator

Overview

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

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

Clinical Trials