Paresthesia-Free Fast-Acting Subperception (FAST) Study (FAST)
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boston Scientific WaveWriter SCS System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Stimulation
Eligibility 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
Sites / Locations
- Vitamed ResearchRecruiting
- Denver Back Pain SpecialistsRecruiting
- South Lake Pain Institute, IncRecruiting
- The Orthopaedic InstituteRecruiting
- University of Chicago HospitalRecruiting
- Goodman Campbell Brain and SpineRecruiting
- Willis-Knighton River Cities Clinical Research CenterRecruiting
- Montefiore Medical CenterRecruiting
- The Center for Clinical ResearchRecruiting
- Cleveland Clinic Foundation
- Pacific Sports and Spine, LLCRecruiting
- PCPMG Clinical Research Unit, LLCRecruiting
- Acute and Chronic Pain TherapiesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WaveWriter Settings
Arm Description
Outcomes
Primary Outcome Measures
Targeted Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Secondary Outcome Measures
Full Information
NCT ID
NCT04618471
First Posted
October 31, 2020
Last Updated
October 4, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04618471
Brief Title
Paresthesia-Free Fast-Acting Subperception (FAST) Study
Acronym
FAST
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WaveWriter Settings
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Boston Scientific WaveWriter SCS System
Intervention Description
WaveWriter SCS Programming
Primary Outcome Measure Information:
Title
Targeted Pain Responder Rate
Description
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Time Frame
3 months post-activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Lewis
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Vitamed Research
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Denver Back Pain Specialists
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
South Lake Pain Institute, Inc
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
The Orthopaedic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Goodman Campbell Brain and Spine
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Willis-Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Terminated
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Acute and Chronic Pain Therapies
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
12. IPD Sharing Statement
Links:
URL
http://www.thefaststudy.com
Description
The FAST Study for Chronic Pain
Learn more about this trial
Paresthesia-Free Fast-Acting Subperception (FAST) Study
We'll reach out to this number within 24 hrs