Paresthesia-Free Fast-Acting Subperception (FAST) Study

Boston Scientific

Status

Active, not recruiting

Conditions

Chronic Pain

Treatments

Device: Boston Scientific WaveWriter SCS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04618471

A4099

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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