StimRouter Registry Clinical Protocol

Launched by BIONESS INC · Apr 11, 2019

Keywords

ClinConnect Summary

The StimRouter Registry Clinical Protocol is a study designed to learn more about the long-term effectiveness and safety of the StimRouter Neuromodulation System, a device aimed at helping people with chronic pain caused by nerve issues. Researchers want to find out how well the device works, how safely it can be used, and how it affects patients' quality of life over time. This study is currently looking for participants aged 18 and older who have chronic pain originating from peripheral nerves and have a specific pain level that qualifies them for the device.

To participate, you must be able to understand and sign the consent form and not have certain medical conditions or devices that could interfere with the study, such as implanted pacemakers or specific pain management devices. If you join the study, you'll receive the StimRouter implant, and researchers will monitor your progress to see how you respond to the treatment. This trial offers a chance to contribute valuable information that could help improve care for others suffering from similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is at least 18 years of age at the time of giving informed consent.
• • 2. Subject who has chronic pain of peripheral nerve origin
• • 3. Subject is eligible for StimRouter as determined by the Clinician.
• • 4. Subject has a score of 5 or higher on the Pain NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours
• • 5. Subject is planned to be scheduled for implant of StimRouter.
• • 6. Subject has a life expectancy greater than 6 months as determined by the Clinician.
• • 7. Subject who is able to read, understand, and voluntarily sign the IRB-approved informed consent form prior to the performance of any study-specific procedures.
• • 8. Subject who is able to understand and complete required assessments.
• Exclusion Criteria:
• • 1. Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
• • 2. Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
• • 3. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
• • 4. Subject who has an implanted device in the area for StimRouter implantation without sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices.
• • 5. Subject who requires, or is likely to require, diathermy at the implant site.
• • 6. Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
• • 7. Subject who has a cancerous lesion present near the target stimulation point.
• • 8. Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
• • 9. Subject who has an active systemic infection.
• • 10. Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
• • 11. Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
• • 12. Subject who currently require or is likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
• • 13. Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
• • 14. Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
• • 15. Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
• • 16. Subject who is in litigation related to their pain, or who has a pending or active worker's compensation claim. (A patient receiving long-term medical care from a settled Worker-s Compensation claim would not be excluded.)
• • 17. Subject who declines to provide written consent or follow-up.