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Paresthesia-Free Fast-Acting Subperception (FAST) Study

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04618471
Collaborator
(none)
66
Enrollment
12
Locations
1
Arm
54.7
Anticipated Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Boston Scientific WaveWriter SCS System
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: WaveWriter Settings

Device: Boston Scientific WaveWriter SCS System
WaveWriter SCS Programming

Outcome Measures

Primary Outcome Measures

  1. Targeted Pain Responder Rate [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

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Vitamed Research Palm Desert California United States 92260
2 Denver Back Pain Specialists Greenwood Village Colorado United States 80111
3 The Orthopaedic Institute Gainesville Florida United States 32607
4 University of Chicago Hospital Chicago Illinois United States 60637
5 Goodman Campbell Brain and Spine Carmel Indiana United States 46032
6 Willis-Knighton River Cities Clinical Research Center Shreveport Louisiana United States 71105
7 Montefiore Medical Center Bronx New York United States 10461
8 The Center for Clinical Research Winston-Salem North Carolina United States 27103
9 Cleveland Clinic Foundation Cleveland Ohio United States 44195
10 Pacific Sports and Spine, LLC Eugene Oregon United States 97401
11 PCPMG Clinical Research Unit, LLC Greenville South Carolina United States 29621
12 EvergreenHealth Pain Care Kirkland Washington United States 98034

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT04618471
Other Study ID Numbers:
  • A4099
First Posted:
Nov 6, 2020
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
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:
Paresthesia
Chronic Pain

Study Results

No Results Posted as of Aug 5, 2022