Study Stopped
Study follow-up activities affected by COVID-19
Fast-Acting Subperception Study (FAST)
FAST
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain (COMBO Study)
1 other identifier
interventional
41
1 country
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started Nov 2019
Shorter than P25 for not_applicable chronic-pain
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2019
CompletedFirst Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedResults Posted
Study results publicly available
January 24, 2022
CompletedJanuary 24, 2022
January 1, 2022
10 months
January 14, 2020
October 7, 2021
January 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
3 months post-randomization
Study Arms (2)
WaveWriter Settings
ACTIVE COMPARATORWaveWriter Programming
Conventional Settings
ACTIVE COMPARATORConventional Programming
Interventions
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
Eligibility Criteria
You may qualify if:
- Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- years of age or older at time of enrollment
- 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
You may not qualify if:
- Any pain-related diagnosis or medical/psychological condition 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Center for Pain and Supportive Care
Phoenix, Arizona, 85028, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401, United States
Precision Spine Care
Tyler, Texas, 75701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roshini Jain, Sr. Director Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Wallace
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 18, 2020
Study Start
November 26, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
January 24, 2022
Results First Posted
January 24, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share