Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Abbott Medical Devices
Study ID
NCT03876054
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain

Eligibility Criteria

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

Interventions

  • Spinal cord stimulation (SCS) — DEVICE
    Subjects will be implanted with market-released Abbott SCS systems
  • Dorsal root ganglion stimulation (DRG) — DEVICE
    Subjects will be implanted with market-released Abbott DRG system

Study Details

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Key Dates

Start date
Mar 13, 2019
Status verified
Jan 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Spinal cord stimulation (SCS)
    Subjects using Abbott SCS systems
  • Arm: Dorsal root ganglion stimulation (DRG)
    Subjects using Abbott DRG system

Primary Outcome Measure

Rate of device and procedure related adverse events, deaths, and device deficiencies [ Time Frame: Baseline ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Phoenician Centers for Research & InnovationPhoenixArizona85021-
Pain Institute of Southern ArizonaTucsonArizona85718-
California Orthopedics & SpineLarkspurCalifornia94939-
Restore Orthopedics & Spine CenterOrangeCalifornia92868-
Foothills Pain Management ClinicPomonaCalifornia91767-
Pacific Research InstituteSanta RosaCalifornia95403-
University of Florida Department of AnesthesiaGainesvilleFlorida32610-
Rush University Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Goodman Campbell Brain and SpineIndianapolisIndiana46032-
NuraEdinaMinnesota55435-
Twin Cities Pain ClinicEdinaMinnesota55439-
Mayo ClinicRochesterMinnesota55905-
Saint Louis Pain ConsultantsChesterfieldMissouri63017-
Advanced Pain CareHendersonNevada89052-
Nevada Advanced Pain SpecialistsRenoNevada89511-
Ainsworth Institute of Pain ManagementNew YorkNew York10022-
Unity Spine CenterRochesterNew York14626-
The Spine & Pain Institute of New YorkStaten IslandNew York10305-
Premier Pain SolutionsAshevilleNorth Carolina28803-
Adena Bone and Joint CenterChillicotheOhio45601-
Premier Pain Treatment InstituteLovelandOhio45140-
Pacific Sports & SpineEugeneOregon97401-
Spinal DiagnosticsTualatinOregon97062-
Center for Interventional Pain & SpineExtonPennsylvania19341-
Expert PainHoustonTexas77079-
Central Texas Pain InstituteKilleenTexas76542-
Integrated Pain AssociatesKilleenTexas76542-
Advanced Pain CareRound RockTexas78664-
The Spine & Nerve Center of St Francis HospitalCharlestonWest Virginia25301-

Find similar trials in Phoenix, AZ

By research site
Phoenician Centers for Research & Innovation· Phoenix, AZPain Institute of Southern Arizona· Tucson, AZCalifornia Orthopedics & Spine· Larkspur, CARestore Orthopedics & Spine Center· Orange, CAFoothills Pain Management Clinic· Pomona, CAPacific Research Institute· Santa Rosa, CA

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