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StimRouter Registry Clinical Protocol

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ClinicalTrials.gov Identifier: NCT03913689
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Bioness Inc

Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Peripheral Neuropathy Nervous System Diseases Peripheral Nervous System Diseases Peripheral Nervous System Problem Peripheral Nerve Injuries Peripheral Nervous Device: StimRouter Neuromodulation System

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 173 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : April 30, 2027
Estimated Study Completion Date : April 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
StimRouter Neuromodulation System
Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin
Device: StimRouter Neuromodulation System
An implantable neuromodulation device that treats chronic peripheral nerve pain.




Primary Outcome Measures :
  1. Change in Pain from Screening through 6 Months [ Time Frame: Month 6 ]
    Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale


Secondary Outcome Measures :
  1. Change in Pain Severity post-implantation [ Time Frame: Month 6 ]
    Average change from baseline to month 6 post-implantation in Pain Severity score as measured through the BPI-SF

  2. Change in Pain Interference post-implantation [ Time Frame: Month 6 ]
    Average change from baseline to month 6 post-implantation in Pain Interference score as measured through the BPI-SF

  3. Change in Health-related Quality of Life [ Time Frame: MOnth 6 ]
    Average change from baseline to month 6 in health-related quality of life as assess by the VR-12 questionnaire

  4. Change in Patient Global Impression of change [ Time Frame: Month 6 ]
    Average change from baseline to month 6 in patient global impression of change (PGIC)

  5. Patient Treatment Satisfaction [ Time Frame: Month 6 ]
    Overall patient treatment satisfaction survey

  6. Pain medication use [ Time Frame: Month 6 ]
    Decrease in chronic pain related medication intake at month 6 when compared to baseline


Other Outcome Measures:
  1. Change in average pain [ Time Frame: Month 12 ]
    Average change from baseline to Month 12 post-implantation measured through a NPRS scale

  2. Change in average pain [ Time Frame: Month 24 ]
    Average change from baseline to Month 24 post-implantation measured through a NPRS scale

  3. Change in Pain Severity [ Time Frame: Month 12 ]
    Average change from baseline to Month 12 post-implantation in Pain Severity measured through the BPI-SF

  4. Change in Pain Severity [ Time Frame: Month 24 ]
    Average change from baseline to Month 24 post-implantation in Pain Severity measured through the BPI-SF

  5. Change in Pain Interference [ Time Frame: Month 12 ]
    Average change from baseline to Month 12 post-implantation in Pain Interference measured through the BPI-SF

  6. Change in Pain Interference [ Time Frame: Month 24 ]
    Average change from baseline to Month 24 post-implantation in Pain Interference measured through the BPI-SF

  7. Change in Health-related Quality of Life [ Time Frame: Month 12 ]
    Average change from baseline to month 12 in health-related quality of life as assess by the VR-12 questionnaire

  8. Change in Health-related Quality of Life [ Time Frame: Month 24 ]
    Average change from baseline to month 24 in health-related quality of life as assess by the VR-12 questionnaire

  9. Change in Patient Global Impression of Change [ Time Frame: Month 12 ]
    Average change from baseline to month 12 in patient global impression of change (PGIC)

  10. Change in Patient Global Impression of Change [ Time Frame: Month 24 ]
    Average change from baseline to month 24 in patient global impression of change (PGIC)

  11. Pain Medication Use [ Time Frame: Month 12 ]
    Decrease in chronic pain related medication intake at month 12 when compared to baseline

  12. Pain Medication Use [ Time Frame: Month 24 ]
    Decrease in chronic pain related medication intake at month 24 when compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Up to 173 adult subjects (18 years or older) who have chronic pain of peripheral nerve origin, or other causes for which the Clinician determines StimRouter is the appropriate therapy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913689


Contacts
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Contact: Blake Barrington 919-666-5758 blake.barrington@bioventus.com
Contact: Roxanne Sumner 919-474-6683 roxanne.sumner@bioventus.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Phirum Nguyen    858-822-3108    psnguyen@health.ucsd.edu   
Principal Investigator: Joel Castallenos, M.D.         
California Orthopedics & Spine Recruiting
Larkspur, California, United States, 94939
Contact: Kate Kennedy       katelkennedy@me.com   
Principal Investigator: Ramana Naidu, MD         
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Omar Altirkawi       omar97@stanford.edu   
Principal Investigator: Einar Ottestad, M.D.         
United States, Connecticut
Stamford Hospital Completed
Stamford, Connecticut, United States, 06905
United States, District of Columbia
International Spine,Pain and Performance Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Selma Paul    202-808-8295    spaul@isppcenter.com   
Principal Investigator: Mehul Desai, M.D.         
United States, Louisiana
Warner Orthopedics Recruiting
Baton Rouge, Louisiana, United States, 70817
Contact: Lauren Broussard, NP    225-754-8888    lauren@warnerorthopedics.com   
Principal Investigator: Meredith Warner, MD         
United States, Pennsylvania
Albert Einstein/Moss Rehab Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Marianne Pedicone, RN, BSN    215-205-0573    Mpedicone@einstein.edu   
Principal Investigator: Michael Saulino, M.D.         
United States, Virginia
Valley Sports and Spine Clinic Recruiting
Blacksburg, Virginia, United States, 24060
Contact: Katelin Newkirk    540-443-3832    info@valleysportsandspine.com   
Principal Investigator: Ethan Collver, DO         
United States, Wisconsin
Advocate Aurora Health Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Merve Figueira    920-456-4030    Merve.Figueira@aah.org   
Principal Investigator: Mansoor Aman, MD         
Sponsors and Collaborators
Bioness Inc
Investigators
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Study Chair: Keith McBride Bioness Inc
Study Director: Eric Grigsby, MD Bioness Inc
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Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT03913689    
Other Study ID Numbers: CP-00001
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bioness Inc:
peripheral nerve stimuation (PNS)
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Peripheral Nerve Injuries
Chronic Pain
Pain
Neurologic Manifestations
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries