Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spi… (NCT07507422) | Clinical Trial Compass
RecruitingNot Applicable
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptivâ„¢ Spinal Cord Stimulation Therapy
United States970 participantsStarted 2026-04-17
Plain-language summary
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptivâ„¢ Spinal Cord Stimulation therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years of age or older
✓. Patient must be SCS therapy naïve
✓. A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study.
✓. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable
✓. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat
✓. Patient must have an on-label indication specific to geography.
✓. Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.
Exclusion criteria
✕. Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system)
✕. Has a complex pain pattern that involves both upper and lower limbs or back and upper limb
✕. Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
✕. Has a planned interventional procedure within 6 weeks (+/- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
What they're measuring
1
Percentage of implanted patients who have a ≥ 50% improvement in pain score as assessed by numeric pain rating scale (NPRS) from baseline for the predominant pain being treated at 6 months following device activation
Timeframe: Baseline and 6 months after device activation
2
Percentage of implanted patients who are a composite responder at 6 months following device activation
Timeframe: Baseline and 6 months after device activation
✕. Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study, as determined by the Investigator
✕. Subjects with PCS total score \>30 are not eligible unless ALL of the following are met:
✕. Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation.
✕. Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up