Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
NCT ID: NCT03251937
Last Updated: 2021-04-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
97 participants
INTERVENTIONAL
2018-01-09
2020-03-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
NCT04676022
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
NCT03756012
Wireless Spinal Cord Stimulation for Chronic Pain
NCT02514590
High Frequency (1000Hz) Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back
NCT03818074
Epidural Stimulation in Chronic Spinal Cord Injury Patients
NCT05690074
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spinal Cord Stimulation
Spectra WaveWriter SCS System
Spectra WaveWriter SCS System
Multiple modalities of stimulation therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spectra WaveWriter SCS System
Multiple modalities of stimulation therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 22 years of age or older at time of enrollment
* Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English
* Willing and capable of giving informed consent
Exclusion Criteria
* 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
* Current systemic infection, or local infection in close proximity to the anticipated surgical field
* Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception
* Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roshini Jain
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurovations
Napa, California, United States
Louis J. Raso, MD, PA
Jupiter, Florida, United States
Florida Pain Clinic
Ocala, Florida, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
University of Rochester
Rochester, New York, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Western Reserve Spine and Pain Institute
Kent, Ohio, United States
Toledo Clinic
Toledo, Ohio, United States
West Chester Hospital, LLC
West Chester, Ohio, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Spine Team Texas
Rockwall, Texas, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Advanced Pain Management Appleton
Appleton, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A4064
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.