Chronic PainFASTNCT04231409
Fast-Acting Subperception Study (FAST)
A study testing Boston Scientific Spectra WaveWriter SCS System in people with Chronic Pain, run by Boston Scientific Corporation at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Boston Scientific Spectra WaveWriter SCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Nov 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain 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 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
Center for Pain and Supportive Care
Phoenix, Arizona, 85028
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Precision Spine Care
Tyler, Texas, 75701
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: 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)
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
- Conditions
- Chronic Pain
- Being tested
- Boston Scientific Spectra WaveWriter SCS System
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Spectra WaveWriter SCS SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| WaveWriter Settings | Active comparator | WaveWriter Programming Receives: Device: Boston Scientific Spectra WaveWriter SCS System |
| Conventional Settings | Active comparator | Conventional Programming Receives: Device: Boston Scientific Spectra WaveWriter SCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Nov 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Study follow-up activities affected by COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wallace, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231409
- Sponsor's protocol ID
- 92285183
- Acronym
- FAST
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2020
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04231409
- Acronym / sponsor ID
- FAST / 92285183
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study follow-up activities affected by COVID-19
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WaveWriter Settings | Active comparator | Device: Boston Scientific Spectra WaveWriter SCS SystemWaveWriter Programming |
| Conventional Settings | Active comparator | Device: Boston Scientific Spectra WaveWriter SCS SystemConventional Programming |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic pain 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 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Scientific Spectra WaveWriter SCS SystemThe 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. | Device | Conventional Settings, WaveWriter Settings |
Primary outcome
Overall Pain Responder Rate
Time frame: 3 months post-randomization
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wallace principal investigator
University of California, San Diego
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Spectra WaveWriter SCS System in people with Chronic Pain, run by Boston Scientific Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Pain Responder Rate (time frame: 3 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.