StimRouter Registry Clinical Protocol

Chronic Pain Clinical Trial

Official title:

A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness StimRouter Neuromodulation System in Subjects With Chronic Pain of Peripheral Nerve Origin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913689
• Other study ID #: CP-00001
• Status: Recruiting
• Start date: June 26, 2019
• Est. completion date: April 30, 2028

Study information

• Verified date: September 2022
• Source: Bioness Inc
• Contact: Blake Barrington
• Phone: 919-666-5758
• Email: blake.barrington[@]bioventus.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.

Description:

This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 173
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Nervous System Diseases
• Peripheral Nerve Injuries
• Peripheral Nervous System Diseases
• Peripheral Nervous System Problem
• Peripheral Neuropathy

Intervention

Device:
• StimRouter Neuromodulation System
An implantable neuromodulation device that treats chronic peripheral nerve pain.

Locations

Country	Name	City	State
United States	Warner Orthopedics	Baton Rouge	Louisiana
United States	Valley Sports and Spine Clinic	Blacksburg	Virginia
United States	Albert Einstein/Moss Rehab	Elkins Park	Pennsylvania
United States	University of California San Diego	La Jolla	California
United States	California Orthopedics & Spine	Larkspur	California
United States	Advocate Aurora Health	Oshkosh	Wisconsin
United States	Stanford University	Redwood City	California
United States	Stamford Hospital	Stamford	Connecticut
United States	International Spine,Pain and Performance Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bioness Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in average pain	Average change from baseline to Month 12 post-implantation measured through a NPRS scale	Month 12
Other	Change in average pain	Average change from baseline to Month 24 post-implantation measured through a NPRS scale	Month 24
Other	Change in Pain Severity	Average change from baseline to Month 12 post-implantation in Pain Severity measured through the BPI-SF	Month 12
Other	Change in Pain Severity	Average change from baseline to Month 24 post-implantation in Pain Severity measured through the BPI-SF	Month 24
Other	Change in Pain Interference	Average change from baseline to Month 12 post-implantation in Pain Interference measured through the BPI-SF	Month 12
Other	Change in Pain Interference	Average change from baseline to Month 24 post-implantation in Pain Interference measured through the BPI-SF	Month 24
Other	Change in Health-related Quality of Life	Average change from baseline to month 12 in health-related quality of life as assess by the VR-12 questionnaire	Month 12
Other	Change in Health-related Quality of Life	Average change from baseline to month 24 in health-related quality of life as assess by the VR-12 questionnaire	Month 24
Other	Change in Patient Global Impression of Change	Average change from baseline to month 12 in patient global impression of change (PGIC)	Month 12
Other	Change in Patient Global Impression of Change	Average change from baseline to month 24 in patient global impression of change (PGIC)	Month 24
Other	Pain Medication Use	Decrease in chronic pain related medication intake at month 12 when compared to baseline	Month 12
Other	Pain Medication Use	Decrease in chronic pain related medication intake at month 24 when compared to baseline	Month 24
Primary	Change in Pain from Screening through 6 Months	Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale	Month 6
Secondary	Change in Pain Severity post-implantation	Average change from baseline to month 6 post-implantation in Pain Severity score as measured through the BPI-SF	Month 6
Secondary	Change in Pain Interference post-implantation	Average change from baseline to month 6 post-implantation in Pain Interference score as measured through the BPI-SF	Month 6
Secondary	Change in Health-related Quality of Life	Average change from baseline to month 6 in health-related quality of life as assess by the VR-12 questionnaire	MOnth 6
Secondary	Change in Patient Global Impression of change	Average change from baseline to month 6 in patient global impression of change (PGIC)	Month 6
Secondary	Patient Treatment Satisfaction	Overall patient treatment satisfaction survey	Month 6
Secondary	Pain medication use	Decrease in chronic pain related medication intake at month 6 when compared to baseline	Month 6