Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
RecruitingNCT07507422
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy
- Conditions
- Chronic Pain
- Intractable Pain
- Interventions
- Device: Commercially available Inceptiv™ neurostimulation systems
- Sponsor
- Medtronic
- Start date
- 2026-04-17
- Primary completion
- 2029-06-27
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France, United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 18 years of age or older 2. Patient must be SCS therapy naïve 3. 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. 4. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable 5. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat 6. Patient must have an on-label indication specific to geography. * NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery * NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant. 7. Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months. Exclusion Criteria: 1. 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) 2. Has a complex pain pattern that involves both upper and lower limbs or back and upper limb 3. 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 4. 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 5. 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 6. Subjects with PCS total score \>30 are not eligible unless ALL of the following are met: 1. Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation. 2. Investigator documentation of adequate understanding of therapy, realistic e…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07507422