Fast-Acting Subperception Study (FAST)

Last updated: January 21, 2022
Sponsor: Boston Scientific Corporation
Overall Status: Terminated

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04231409
92285183
  • Ages > 22
  • All Genders

Study Summary

Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater orequal to leg pain.
  • 22 years of age or older at time of enrollment
  • Able to independently read and complete all questionnaires and assessments provided inEnglish
  • Signed a valid, IRB-approved informed consent form (ICF) provided in English

Exclusion

Key Exclusion Criteria:

  • Any pain-related diagnosis or medical/psychological condition that, in the clinician'sbest 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 not usingadequate contraception
  • Participating, or intends to participate, in another clinical trial that may influencethe data that will be collected for this study

Study Design

Total Participants: 41
Study Start date:
November 26, 2019
Estimated Completion Date:
October 01, 2020

Connect with a study center

  • Center for Pain and Supportive Care

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Boston Scientific Clinical Research

    Valencia, California 91355
    United States

    Site Not Available

  • Willis-Knighton River Cities Clinical Research Center

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • The Center for Clinical Research, LLC

    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

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Site Not Available

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