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NCT01719055Recruiting

RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Boston Scientific Corporation

Start Date

11/19/2012

Completion Date

5/1/2035

Summary

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use \- and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Detailed Description

The study is a prospective, multi-center, global, post-market study of Boston Scientific neurostimulation systems for pain. The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use * Signed a valid, IRB/EC-approved informed consent form * 18 years of age or older Key Exclusion Criteria: * Contraindicated for Boston Scientific neurostimulation system * Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Interventions

DEVICE

neurostimulation system

Interested in This Trial?

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Conditions

Pain

Locations

Physicians Research Group, LLC

Phoenix, Arizona 85016

United States

Hope Research Institute

Phoenix, Arizona 85018

United States

Banner University Medical Center

Tucson, Arizona 85724

United States

Comprehensive Pain Management Center

Campbell, California 95008

United States

Coastal Research Institute

Carlsbad, California 92009

United States

Pain Medicine Associates, Inc.

Fountain Valley, California 92708

United States

Metropolitan Pain Management Consultants Inc.

Sacramento, California 95821

United States

Huntley Pain Specialists

San Diego, California 92108

United States

Conejo Pain Specialists

Thousand Oaks, California 91362

United States

Denver Back Pain Specialists

Greenwood Village, Colorado 80111

United States

Orlando Health Neuroscience Institute, Inc

Clermont, Florida 34711

United States

South Lake Pain Institute, Inc

Clermont, Florida 34711

United States

University of Florida Shands Hospital

Gainesville, Florida 32608

United States

Louis J. Raso, MD, PA

Jupiter, Florida 33477

United States

Advanced Interventional Pain Management and Research Clinic, Inc.

Miami Gardens, Florida 33169

United States

JM Clinical Research

South Miami, Florida 33143

United States

Tallahassee Neurological Clinic, PA

Tallahassee, Florida 32308

United States

Orthopedic Research Foundation

Savannah, Georgia 31405

United States

Pain Care, LLC

Stockbridge, Georgia 30281

United States

Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic

Chicago, Illinois 60611

United States

Chicago Anesthesia Pain Specialists

Chicago, Illinois 60657

United States

Global Scientific Innovations - Advanced Pain Care Clinic

Evansville, Indiana 47714

United States

Summit Research Institute

Fort Wayne, Indiana 46825

United States

Goodman Campbell Brain and Spine

Greenwood, Indiana 46143

United States

American Health Network of Indiana, LLC

Muncie, Indiana 47304

United States

Research Medical Center

Lenexa, Kansas 66214

United States

Neuroscience Associates of Northern Kentucky

Crestview Hills, Kentucky 41017

United States

Bux Pain Management

Danville, Kentucky 40422

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70115

United States

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana 71105

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Beth Israel Deaconess Medical Center

Brookline, Massachusetts 02445

United States

Michigan Pain Specialists

Ann Arbor, Michigan 48108

United States

Insight Institute of Neurosurgery & Neuroscience

Flint, Michigan 48507

United States

Forest Health Medical Center

Ypsilanti, Michigan 48198

United States

Jackson Anesthesia Pain Center, LLC

Jackson, Mississippi 39202

United States

Midwest Pain Center

Chesterfield, Missouri 63005

United States

Saint Louis Pain Consultants

Chesterfield, Missouri 63017

United States

KC Pain Centers

Lee's Summit, Missouri 64086

United States

Hope Research Institute

Las Vegas, Nevada 89106

United States

Albany Medical Center

Albany, New York 12208

United States

New York Presbyterian Hospital

New York, New York 10065

United States

University of Rochester

Rochester, New York 14618

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Spine and Skeletal Pain Medicine

Utica, New York 13502

United States

Carolinas Research Institute, PLLC

Huntersville, North Carolina 28078

United States

Raleigh Neurology Associates, P.A.

Raleigh, North Carolina 27607

United States

The Center for Clinical Research, LLC

Winston-Salem, North Carolina 27103

United States

Case Western Reserve University

Cleveland, Ohio 44106

United States

Ohio State University Medical Center

Columbus, Ohio 43203

United States

University of Toledo Medical Center

Toledo, Ohio 43614

United States

Pacific Sports and Spine, LLC

Eugene, Oregon 97401

United States

Fox Chase Pain Management

Trevose, Pennsylvania 19053

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Florence Neurosurgery and Spine

Florence, South Carolina 29506

United States

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina 29601

United States

Channel Research

Pawleys Island, South Carolina 29585

United States

Balcones Pain Consultants

Austin, Texas 78745

United States

Institute of Precision Pain Medicine

Corpus Christi, Texas 78414

United States

Spine Works Institute

North Richland Hills, Texas 76182

United States

Spine Team Texas

Rockwall, Texas 75032

United States

Precision Spine Care

Tyler, Texas 75701

United States

Washington Center for Pain Management

Bellevue, Washington 98004

United States

EvergreenHealth Pain Care

Kirkland, Washington 98034

United States

Swedish Neuroscience Institute

Seattle, Washington 98122

United States

West Virginia University Hospitals

Morgantown, West Virginia 26506

United States

Advanced Pain Management Appleton

Greenfield, Wisconsin 53221

United States

CENIT Centro de Neurociencias, Investigacion y Tratamiento

Buenos Aires,

Argentina

Interventus Pain Specialists

Auchenflower,

Australia

Hunter Clinical Research

Broadmeadow,

Australia

Hunter Pain Clinic

Broadmeadow,

Australia

Green Lizard Science

Claremont,

Australia

Sydney Spine and Pain Pty Ltd

Hurstville,

Australia

Sunshine Coast Clinical Research

Noosa,

Australia

Pain Matrix

Waurn Ponds,

Australia

Pain Medicine of South Australia

Wayville,

Australia

AZ Sint-Lucas

Ghent,

Belgium

AZ Delta

Roeselare,

Belgium

London Health Sciences Centre

London,

Canada

Hopital de Enfant-Jesus

Québec,

Canada

Regina General Hospital

Regina,

Canada

Fundacion Clinica Valle del Lili

Cali,

Colombia

Fundacion Cardiovascular de Colombia Floridablanca

Floridablanca,

Colombia

Odense University Hospital

Odense,

Denmark

Universitatsklinik Charite Berlin

Berlin,

Germany

University KH Bonn

Bonn,

Germany

Uniklinik Köln

Cologne,

Germany

Uniklinik Köln

Cologne,

Germany

Universitaetsklinikum Dusseldorf

Düsseldorf,

Germany

Algesiologikum

München,

Germany

Sheba Medical Center

Ramat Gan,

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv,

Israel

Fondazione Salvatore Maugeri IRCCS

Pavia,

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa,

Italy

Kobe University Hospital

Kobe,

Japan

Hyogo College of Medicine Hospital

Nishinomiya-shi,

Japan

Okayama University Hospital

Okayama,

Japan

Sakai Hospital Kinki University Faculty of Medicine

Sakaishi,

Japan

Ziekenhuis Rijnstate

Velp,

Netherlands

Hospital General de Ciudad Real

Ciudad Real,

Spain

Hospital La Paz

Madrid,

Spain

Hospital La Princesa

Madrid,

Spain

Hospital Puerta de Hierro

Madrid,

Spain

Hospital Universitario Infanta Elena

Madrid,

Spain

Clinica Universidad de Navarra

Pamplona,

Spain

Hospital Donostia

San Sebastián,

Spain

H. Marques De Valdecilla

Santander,

Spain

Hospital Virgen De La Salud

Toledo,

Spain

Hospital General de Valencia

Valencia,

Spain

Sahlgrenska University Hospital

Gothenburg,

Sweden

Ospedale Regionale di Lugano

Viganello,

Switzerland

Basildon and Thurrock University Hospitals NHS

Basildon,

United Kingdom

Southmead Hospital Bristol

Bristol,

United Kingdom

The General Infirmary

Leeds,

United Kingdom

Chelsea and Westminster Hospital

London,

United Kingdom

St. Bartholomews Hospital

London,

United Kingdom

James Cook University Hospital

Middlesbrough,

United Kingdom

Royal National Orthopaedic Hospital

Stanmore,

United Kingdom