Paresthesia-Free Fast-Acting Subperception (FAST) Study

Last updated: April 2, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Boston Scientific WaveWriter SCS System

Clinical Study ID

NCT04618471
A4099
  • Ages > 22
  • All Genders

Study Summary

Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6months with back pain greater or equal to leg pain.

  • 22 years of age or older when written informed consent is obtained

  • Able to independently read and complete all questionnaires and assessments providedin English

  • Signed a valid, IRB-approved informed consent form (ICF) provided in English

Exclusion

Key Exclusion Criteria:

  • Any pain-related diagnosis or medical/psychological condition or external factorsthat, in the clinician's best judgment, might confound reporting of study outcomes

  • Significant cognitive impairment that, in the opinion of the Investigator, wouldreasonably be expected to impair the study candidate's ability to participate in thestudy

  • Breast-feeding or planning to get pregnant during the course of the study or notusing adequate contraception

  • Participating, or intends to participate, in another clinical trial that mayinfluence the data that will be collected for this study

Study Design

Total Participants: 177
Treatment Group(s): 1
Primary Treatment: Boston Scientific WaveWriter SCS System
Phase:
Study Start date:
February 10, 2021
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Vitamed Research

    Palm Desert, California 92260
    United States

    Site Not Available

  • Denver Back Pain Specialists

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • South Lake Pain Institute, Inc

    Clermont, Florida 34711
    United States

    Site Not Available

  • The Orthopaedic Institute

    Gainesville, Florida 32607
    United States

    Site Not Available

  • University of Chicago Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Willis-Knighton River Cities Clinical Research Center

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pacific Sports and Spine, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Acute and Chronic Pain Therapies

    Bellevue, Washington 98005
    United States

    Site Not Available

  • EvergreenHealth Pain Care

    Kirkland, Washington 98034
    United States

    Site Not Available

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