RECRUITING

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

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Conditions

Painstimulationimplantablepulse generatorback painchronic painleg pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Directions for Use \- and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Official Title

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

Quick Facts

Study Start:2012-11-19
Study Completion:2035-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01719055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
  2. * Signed a valid, IRB/EC-approved informed consent form
  3. * 18 years of age or older
  1. * Contraindicated for Boston Scientific neurostimulation system
  2. * 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

Contacts and Locations

Study Contact

Thanh Hoang, MS
CONTACT
855-213-9890
BSNClinicalTrials@bsci.com
Stephanie Delvaux
CONTACT
855-213-9890
BSNClinicalTrials@bsci.com

Principal Investigator

Natalie Bloom Lyons
STUDY_DIRECTOR
Boston Scientific Corporation

Study Locations (Sites)

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
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
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
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
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

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Natalie Bloom Lyons, STUDY_DIRECTOR, Boston Scientific Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-11-19
Study Completion Date2035-05

Study Record Updates

Study Start Date2012-11-19
Study Completion Date2035-05

Terms related to this study

Keywords Provided by Researchers

  • stimulation
  • implantable
  • pulse generator
  • back pain
  • chronic pain
  • leg pain

Additional Relevant MeSH Terms

  • Pain