Paresthesia-Free Fast-Acting Subperception (FAST) Study
Active, not recruitingNot applicableNCT04618471
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Device: Boston Scientific WaveWriter SCS System
- Sponsor
- Boston Scientific Corporation
- Start date
- 2021-02-10
- Primary completion
- 2022-12-14
- Sex
- All
- Age range
- from 22 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 13
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04618471