Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
- Conditions
- Chronic Pain
- Registration Number
- NCT03876054
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Subject must provide written informed consent prior to any clinical investigation<br> related procedure.<br><br> 2. Subject is at least 18 years (or the minimum age required by local law to consent<br> for participation in a clinical investigation) or older at the time of enrollment.<br><br> 3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60<br> days of baseline.<br><br> 4. Subject has a baseline (with no stimulation) pain NRS of = 6.<br><br>Exclusion Criteria:<br><br> 1. Subject is enrolled, or intends to participate, in a competing clinical study, as<br> determined by Abbott.<br><br> 2. Presence of other anatomic or comorbid conditions, or other medical, social, or<br> psychological conditions that, in the investigator's opinion, could limit the<br> subject's ability to participate in the clinical investigation or to comply with<br> follow-up requirements.<br><br> 3. Subject has or is scheduled to receive an intrathecal pump.<br><br> 4. Subject is part of a vulnerable population.<br><br> 5. Subject has an existing implanted neuromodulation device to address their chronic<br> pain.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method