Actively Recruiting
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Led by Medtronic · Updated on 2026-05-04
970
Participants Needed
3
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Patient must be spinal cord stimulation (SCS) therapy naive
- Clinical decision made to receive an Inceptiv184 SCS system pending satisfactory trial results
- On stable opioid dosage for 3 months prior to enrollment, if applicable
- Pain intensity of 6 or higher on numeric pain rating scale in predominant pain areas
- On-label indication specific to geography, including upper limb radicular pain
- Diagnosis of chronic back and/or limb pain lasting at least six months
You will not qualify if you...
- Existing or planned active implantable neuromodulation device during 5-year follow-up
- Complex pain pattern involving both upper and lower limbs or back and upper limb
- Planned major medical procedure within 6 months before or after implant
- Planned interventional procedure within 6 weeks before or after implant
- Untreated or unstable major psychiatric disorder interfering with study
- PCS total score over 30 unless specific conditions met
- Major untreated or refractory progressive disease or injury interfering with study
- Drug or alcohol dependency admissions within past 12 months or ongoing substance abuse
- Current prescription of 90 morphine milligram equivalents (MME) per day or more
- Predominant mechanical back pain from facet or sacroiliac joint pain
- Mechanical spine instability as determined by investigator
- Active systemic or local infection delaying trial or implant
- Pregnant or planning pregnancy
- Life expectancy less than 1 year
- Involved in injury claims, litigation, or worker's compensation
- Condition increasing perioperative risk as determined by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Center for Pain and Supportive Care
Phoenix, Arizona, United States, 85028
Actively Recruiting
2
Christian Hospital
St Louis, Missouri, United States, 63136-6119
Actively Recruiting
3
North Texas Orthopedics and Spine Center
Houston, Texas, United States, 76051-3930
Actively Recruiting
Research Team
S
Study Inbox
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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