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
Qualifiers
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 design
Treatments tested in this trial
- Commercially available Inceptiv™ neurostimulation systems
Treatment groups
970 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov