Trial Outcomes & Findings for Paresthesia-Free Fast-Acting Subperception (FAST) Study (NCT NCT04618471)
NCT ID: NCT04618471
Last Updated: 2025-12-23
Results Overview
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
3 months post-activation
Results posted on
2025-12-23
Participant Flow
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 At the time of analysis, 104 provided informed consent, of which 62 were screen failures, 11 were withdrawn.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).
Participant milestones
| Measure |
WaveWriter Settings
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Overall Study
STARTED
|
177
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
157
|
Reasons for withdrawal
| Measure |
WaveWriter Settings
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Overall Study
Screen Failure
|
62
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Various other reasons
|
2
|
|
Overall Study
Pending study evaluation and completion of 3-Month post activation visit
|
84
|
Baseline Characteristics
At the time of analysis, three subjects had no completed the Baseline VRS questionnaire.
Baseline characteristics by cohort
| Measure |
WaveWriter Settings
n=86 Participants
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Age, Continuous
|
59.67 years
STANDARD_DEVIATION 13.08 • n=86 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
56 Participants
n=86 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
30 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Race · Black, of African heritage
|
13 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
65 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
5 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Race · Not disclosed
|
2 Participants
n=86 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=86 Participants
|
|
Average overall pain (VRS)
|
7.4 units on a scale
STANDARD_DEVIATION 1.3 • n=83 Participants • At the time of analysis, three subjects had no completed the Baseline VRS questionnaire.
|
PRIMARY outcome
Timeframe: 3 months post-activationPopulation: Interim analysis of 20 activated subjects at 3-Month Visit.
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Outcome measures
| Measure |
WaveWriter Settings
n=20 Participants
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Targeted Pain Responder Rate
|
16 Participants
|
Adverse Events
WaveWriter Settings
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
WaveWriter Settings
n=104 participants at risk
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.9%
3/104 • Number of events 3 • 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.
|
|
Infections and infestations
Bacteraemia
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Infections and infestations
COVID-19
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Infections and infestations
Extradural abscess
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Infections and infestations
Sepsis
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.96%
1/104 • Number of events 1 • 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.
|
Other adverse events
| Measure |
WaveWriter Settings
n=104 participants at risk
Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.96%
1/104 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.96%
1/104 • Number of events 1 • 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.
|
|
General disorders
Implant site pain
|
0.96%
1/104 • Number of events 2 • 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.
|
|
General disorders
Pain
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Nervous system disorders
Paraesthesia
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Product Issues
Device stimulation issue
|
0.96%
1/104 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.96%
1/104 • Number of events 1 • 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.
|
Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER