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Paresthesia-Free Fast-Acting Subperception (FAST) Study (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04618471
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Boston Scientific WaveWriter SCS System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: WaveWriter Settings Device: Boston Scientific WaveWriter SCS System
WaveWriter SCS Programming


Outcome Measures
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Primary Outcome Measures :
  1. Targeted Pain Responder Rate [ Time Frame: 3 months post-activation ]
    Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months 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 provided in English
  • Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

  • Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
  • Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
  • Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
  • Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618471


Contacts
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Contact: Alison Lewis 855-213-9890 BSNClinicalTrials@bsci.com
Contact: Diane Keesey 855-213-9890 BSNClinicalTrials@bsci.com

Locations
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United States, California
Vitamed Research Recruiting
Palm Desert, California, United States, 92260
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Colorado
Denver Back Pain Specialists Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Florida
The Orthopaedic Institute Recruiting
Gainesville, Florida, United States, 32607
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Illinois
University of Chicago Hospital Recruiting
Chicago, Illinois, United States, 60637
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Indiana
Goodman Campbell Brain and Spine Recruiting
Carmel, Indiana, United States, 46032
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Louisiana
Willis-Knighton River Cities Clinical Research Center Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Ohio
Cleveland Clinic Foundation Terminated
Cleveland, Ohio, United States, 44195
United States, Oregon
Pacific Sports and Spine, LLC Recruiting
Eugene, Oregon, United States, 97401
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, South Carolina
PCPMG Clinical Research Unit, LLC Recruiting
Greenville, South Carolina, United States, 29601
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
United States, Washington
Acute and Chronic Pain Therapies Recruiting
Bellevue, Washington, United States, 98005
Contact: Boston Scientific Clinical Research    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Natalie Bloom Lyons Boston Scientific Corporation
More Information
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Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04618471    
Other Study ID Numbers: A4099
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Scientific Corporation:
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Paresthesia
Chronic Pain
Pain
Neurologic Manifestations
 Somatosensory Disorders
Sensation Disorders
Nervous System Diseases