Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Medtronic
Study ID
NCT07507422
Status
Recruiting
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Conditions

  • Chronic Pain
  • Intractable Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Commercially available Inceptiv™ neurostimulation systems — DEVICE
    Spinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptiv™ neurostimulation systems

Study Details

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.

Key Dates

Start date
Apr 17, 2026
Status verified
Mar 2026
Primary completion
Jun 27, 2029
Completion
Jan 11, 2034

Study Design

Enrollment
970 participants (estimated)

Arms

  • Arm: PERSIST Cohort

Primary Outcome Measure

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 [ Time Frame: Baseline and 6 months after device activation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Center for Pain and Supportive CarePhoenixArizona85028
Krisstin Hammond
Gobi Paramanandam (PRINCIPAL_INVESTIGATOR)
Christian HospitalSt LouisMissouri63136-6119
Maksim Shoykhet
Christopher Beuer (PRINCIPAL_INVESTIGATOR)
North Texas Orthopedics and Spine CenterHoustonTexas76051-3930
Katelynn Traver
Melissa Murphy (PRINCIPAL_INVESTIGATOR)

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Center for Pain and Supportive Care· Phoenix, AZChristian Hospital· St Louis, MONorth Texas Orthopedics and Spine Center· Houston, TX

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