N/A
Completed N=256
Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation
Postoperative Pain · Back Pain
Source: ClinicalTrials.gov NCT02093793 ↗
Enrolled (actual)
256
Serious AEs
2.9%
Results posted
Jul 2020
Primary outcomePrimary: Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates — 0.47; 0.53; 0.4 probability
Summary
To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates |
0.47; 0.53; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be 22 years of age or older at the time of enrollment
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion Criteria
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
- Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- Have a current systemic infection, or local infection in close proximity to anticipated surgical field
- Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
- Be participating in another clinical study that may influence the data collected for the study
Data sourced from ClinicalTrials.gov (NCT02093793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.