Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic
About this trial
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 Inceptiv™ Spinal Cord Stimulation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The intended study population is adults with chronic, intractable pain of the trunk and/or limbs indicated for a Medtronic Inceptiv™ implantable neurostimulation system. Study eligibility criteria must be met to participate in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Commercially available Inceptiv™ neurostimulation systems
DeviceSpinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptiv™ neurostimulation systems
Treatment groups
970 Participants
are divided into 1 treatment groupGroup A: PERSIST Cohort1 intervention
Trial outcomes
Primary outcomes
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
This outcome measures the percentage of implanted patients who demonstrate improvement in pain for the predominant pain condition being treated at 6 months following device activation, compared to baseline. Pain is assessed using the NPRS (with 0=no pain and 10=highest level of pain).
Time frame
Baseline and 6 months after device activation2
Percentage of implanted patients who are a composite responder at 6 months following device activation
A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline.
Time frame
Baseline and 6 months after device activationSecondary outcomes
1
Percentage of implanted patients who are a composite responder
A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline.
Time frame
Baseline and 3 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months after device activation Source ClinicalTrials.gov