A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Part of paid clinical trials in Carlsbad, California.

Sponsor
Boston Scientific Corporation
Study ID
NCT04192591
Status
Active Not Recruiting

Conditions

  • Lumbar Spinal Stenosis

Eligibility Criteria

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

Interventions

  • Superion™ IDS device — DEVICE
    The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.

Study Details

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Key Dates

First listed
Dec 10, 2019
Start date
Jan 30, 2020
Status verified
Aug 2026
Primary completion
Feb 28, 2038
Completion
Feb 28, 2041

Study Design

Enrollment
166 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Superion™ IDS device
    Superion™ Indirect Decompression System (IDS)

Primary Outcome Measure

Rate of success at the 24-month follow-up visit [ Time Frame: 24-Months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Coastal Research Institute, LLCCarlsbadCalifornia92009-
MarinHealth Spine InstituteLarkspurCalifornia94939-
Vitamed ResearchRancho MirageCalifornia92270-
IPM Medical Group Inc.Walnut CreekCalifornia94598-
Holy Cross HospitalFort LauderdaleFlorida33308-
The Orthopaedic InstituteGainesvilleFlorida32607-
Alliance Spine and Pain CentersAtlantaGeorgia30326-
Centurion Spine and PainWaycrossGeorgia31501-
North Idaho Day SurgeryPost FallsIdaho83854-
Rush University Medical CenterChicagoIllinois60612-
Ascension Alexian BrothersElk Grove VillageIllinois60007-
University of Kansas HospitalKansas CityKansas66160-
Neuroscience Research Center, LLCOverland ParkKansas66215-
Brigham and Women's HospitalBostonMassachusetts02115-
Michigan Pain SpecialistsYpsilantiMichigan48198-
Weill Cornell Medical UniversityNew YorkNew York10065-
Pacific Sports and Spine, LLCEugeneOregon97401-
Center for Interventional Pain and SpineLancasterPennsylvania17601-
SC Pain and Spine SpecialistsMurrells InletSouth Carolina29576-
Precision Spine CareTylerTexas75701-
Swedish Health ServicesSeattleWashington98122-
Northwest Pain CareSpokaneWashington99201-
The Spine and Nerve Center of Saint Francis HospitalCharlestonWest Virginia25301-

Find similar trials in Carlsbad, CA

By research site
Coastal Research Institute, LLC· Carlsbad, CAMarinHealth Spine Institute· Larkspur, CAVitamed Research· Rancho Mirage, CAIPM Medical Group Inc.· Walnut Creek, CAHoly Cross Hospital· Fort Lauderdale, FLThe Orthopaedic Institute· Gainesville, FL

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