Saluda Medical ECAP-controlled, Closed-loop SCS Clinical Study
Clinical Trial & Research Study
Saluda ECAP Study: A prospective, multicenter, single-arm study examining ECAP-controlled, closed-loop stimulation with the Evoke Spinal Cord Stimulator (SCS) System to treat patients with chronic pain of the trunk and/or limbs.
- WIRB Protocol #20193179
- Sponsor: Saluda Medical Americas, Inc.
- The study will enroll up to 200 subjects from up to 25 sites in the United States
- The Evoke Closed-loop SCS System measures evoked compound action potentials (ECAPs) during postural changes and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
What is the Evoke Closed-Loop SCS System?
The Evoke® Closed-Loop SCS System is a new type of SCS and is currently being evaluated in the U.S. as an investigational device through the ECAP Clinical Study. Evoke is the only SCS system designed to measure the spinal cord’s response to stimulation and automatically adjust stimulation strength to maintain a consistent level of pain therapy.
About the Study
As part of your participation in the ECAP study, you are required to attend 6 study follow-up sessions. These follow-up visits will take place at 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months after your device is implanted. During these study visits, your doctor will assess how you are responding to the therapy and you will complete questionnaires to measure your pain and quality of life improvements.
Can I Participate?
To be included in the study, you must meet these criteria (Inclusion Criteria):
- Subject has chronic intractable pain of the trunk and/or limbs with a pain score of at least 6 out of 10 in the area intended to be treated with SCS.
- Subject is able to comply with study-related requirements, procedures, and visits.
You may not be eligible for the study if you have any of these criteria (Exclusion Criteria):
- Subject is unable to operate the system.
- Subject is an unsuitable surgical candidate.
- Subject has a condition currently requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
- Subject has another implantable stimulator such as pacemakers or cardioverter defibrillator.
- Subject is <18 years old.
- Subject is pregnant or nursing.
- Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
- Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
- Subject is involved in an injury claim under current litigation or has pending/approved worker’s compensation claim.
- Subject has prior experience with SCS, including trials and implants.
Clinical Study Enrollment Form
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