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Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Recruiting
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

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.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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