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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveWriter Settings | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific WaveWriter SCS System | Device | WaveWriter SCS Programming |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months post-activation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitamed Research | Palm Desert | California | 92260 | United States | ||
| Denver Back Pain Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41803572 | Derived | Anitescu M, Loudermilk E, North J, Wahezi S, Antony A, Leier T, Trainor D, Noles J, Moore G, Lee J, Paez J, Wilson D, Van Belleghem V, Goldberg E. Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study. Pain Ther. 2026 Jun;15(3):643-662. doi: 10.1007/s40122-026-00823-0. Epub 2026 Mar 10. |
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Only consented subjects who meet protocol criteria proceed to activation. The primary endpoint analysis is based on 20 activated subjects at 3-Month Visit. At the time of analysis, 104 provided informed consent, of which 62 were screen failures, 11 were withdrawn. Of the 31 remaining subjects 9 were pending evaluation, 2 had IPG activation and 20 had completed the 3-Month Visit. 73 additional subjects were consented before enrollment was complete. This accounts for the 177 subjects (104+73).
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| ID | Title | Description |
|---|---|---|
| FG000 | WaveWriter Settings | Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2023 |
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| Greenwood Village |
| Colorado |
| 80111 |
| United States |
| Orlando Health Neuroscience Institute | Clermont | Florida | 34711 | United States |
| The Orthopaedic Institute | Gainesville | Florida | 32607 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Goodman Campbell Brain and Spine | Carmel | Indiana | 46032 | United States |
| Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| The Center for Clinical Research | 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 |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | United States |
| Acute and Chronic Pain Therapies | Bellevue | Washington | 98005 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who had completed Baseline Visit at the time of the pre-specified interim analysis of 20 activated subjects at 3-month interim visit. The data reported is from a pre-specified interim analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | WaveWriter Settings | Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Average overall pain (VRS) | Pain intensity is expressed on a 0 - 10 verbal rating scale (VRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". | At the time of analysis, three subjects had no completed the Baseline VRS questionnaire. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Interim analysis of 20 activated subjects at 3-Month Visit. | Posted | Count of Participants | Participants | 3 months post-activation |
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Adverse Event Rates for all Subjects at time of the pre-specified primary endpoint analysis for 20 activated subjects at 3-Month Visit, approximately 7-8 months post informed consent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WaveWriter Settings | Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming | 0 | 104 | 6 | 104 | 6 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Extradural abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Device stimulation issue | Product Issues | MedDRA (23.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
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A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Dec 14, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hispanic or Latino |
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| Native Hawaiian or other Pacific Islander |
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| Not disclosed |
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