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Trial record 4 of 16 for:    Bioness

StimRouter Registry Clinical Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913689
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : June 29, 2020
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 Phase
Chronic Pain Device: StimRouter Neuromodulation System Not Applicable

Detailed Description:
This is a prospective, open-label, long-term, multi-center registry. Up to 1000 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 30 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 60 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 1 month post-implant, 3 months post-implant, 6 months post-implant, 12 months post-implant, and annually thereafter for the duration of the study. Specific assessments will be completed by the subject and clinician at these visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, long-term, multi-center registry
Masking: None (Open Label)
Masking Description: open-label
Primary Purpose: Treatment
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

Arm 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 Numeric Pain Rating Scale (NPRS) from Screening through 60 Months after implant of StimRouter [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    The Numeric Pain Rating Scale is a unidimensional measure of pain intensity in adults including those with chronic pain in which the respondent selects a whole number (0-10) that best reflects the intensity of his/her pain, with 0 being no pain and 10 being the worst possible pain. The scale is shown as a horizontal bar or line to respondents. It will be administered at each study visit to examine changes in subjects' pain over time.

  2. The number of subjects with adverse events and serious adverse events will be assessed throughout the Registry to measure safety of the StimRouter device therapy [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    Safety reporting and assessment will include all adverse events (AEs) and serious adverse events (SAEs) regardless of relationship to the study treatment or intervention. The reporting period will begin when subjects sign the consent form and until the end of study participation.

  3. To assess safety of the StimRouter device therapy, vital signs will be assessed throughout the course of the Registry [ Time Frame: Regular follow-up schedule starting with Screening and until the 60-month visit ]
    Vital signs to be assessed include Height in inches

  4. To assess safety of the StimRouter device therapy, vital signs will be assessed throughout the course of the Registry [ Time Frame: Regular follow-up schedule starting with Screening and until the 60-month visit ]
    Vital signs to be assessed will include weight in pounds

  5. To assess safety of the StimRouter device therapy, vital signs will be assessed throughout the course of the Registry [ Time Frame: Regular follow-up schedule starting with Screening and until the 60-month visit ]
    Vital signs to be assessed include heart rate in beats/min

  6. To assess safety of the StimRouter device therapy, vital signs will be assessed throughout the course of the Registry [ Time Frame: Regular follow-up schedule starting with Screening and until the 60-month visit ]
    Vital signs to be assessed include systolic and diastolic blood pressure in mmHg

  7. To assess safety of the StimRouter device therapy, the focused physical exam will be assessed at Baseline or implant and again at the 60-month visit [ Time Frame: Exams to be conducted at baseline or implant and again at 60-month post-implant ]
    Per standard of care, the study doctor will conduct a physical exam examining the musculoskeletal system and other systems as needed. The exam will include inspection of specific areas of the body for normal or abnormal color, shape, consistency, as well as tests of palpation, percussion, and auscultation.

  8. To assess safety of the StimRouter device therapy, the focused neurological exam will be assessed at Baseline or implant and again at the 60-month visit [ Time Frame: Exams to be conducted at baseline or implant and again at 60-month post-implant ]
    Per standard of care, the study doctor will conduct a neurological exam of the subject covering various areas such as gait and motor coordination, behavior, and speech and will provide an overall assessment of normal or abnormal and comments for any abnormal findings.


Secondary Outcome Measures :
  1. To evaluate the subject's pain prospectively through assessment of Subject's pain etiology: Oswestry Disability Index (ODI) [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    Pain will be assessed using the Oswestry Disability Index (ODI) on a scale of 0-5 with 5 being the most severe disability and focusing on 10 topics concerning pain.

  2. To evaluate changes in medication for pain, the number of subjects who stop use of opioids and other pain medications will be evaluated [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    Review of concomitant medications will occur at each visit to review changes in opioid use as well as other pain medication and anticoagulants

  3. To evaluate the interference of pain on patient function: 36-item Short Form Health Survey (SF-36) [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    Patient function will be assessed at each follow-up visit using the 36-item Short Form Health Survey (SF-36) and consists of eight scaled scores which are the weighted sums of the questions in their section, and include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. In these scales, the lower the score, the more disability. The higher the score, the less disability. Each scale score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.

  4. Subjects' quality of life with treatment will be assessed; The Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    The Brief Pain Inventory - Short Form (BPI-SF) will be completed by subjects with items on a scale of 0 (no pain) to 10 (Pain as bad as you can imagine) and the extent of pain interference on daily activities from 0 (does not interfere) to 10 (completely interferes).

  5. Subjects' impression of improvement with treatment will be assessed [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    Subjects will complete the Patients' Global Impression of Change (PGIC) scale where they will circle on a horizontal scale the degree of change in pain since initial implant of the device and improvement in clinical outcome from 0 (much better) to 10 (much worse).

  6. Subjects' satisfaction with treatment will be assessed: scale [ Time Frame: Regular follow-up schedule until the 60-month visit ]
    A patient satisfaction question will be given which asks the subjects' level of satisfaction with the device on a scale of 1 (very dissatisfied) to 5 (very satisfied) starting with the first visit following implant and until the end of the study



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
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years of age at the time of giving informed consent.
  2. Subject is eligible for StimRouter as determined by the Clinician.
  3. Subject is planned to be scheduled for implant of StimRouter.
  4. Subject has a life expectancy greater than 6 months as determined by the Clinician.
  5. 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.
  6. 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 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.
  4. Subject who requires, or is likely to require, diathermy at the implant site.
  5. Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
  6. Subject who has a cancerous lesion present near the target stimulation point.
  7. Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
  8. Subject who has an active systemic infection.
  9. Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
  10. Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
  11. 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.
  12. Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
  13. Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
  14. Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
  15. 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.)
  16. 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: Sharone Trifskin, MA 661-902-5276 sharone.trifskin@bioness.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Katie Lam, RN, MSN    858-822-0787    kklam@health.ucsd.edu   
Principal Investigator: Krishnan Chakravarthy, M.D.         
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Maryam Khan, CRC    650-721-7252    mkhannn@stanford.edu   
Principal Investigator: Einar Ottestad, M.D.         
Sub-Investigator: Ranjini Reddy-Deo, M.D.         
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06905
Contact: Maryanne Ducey    203-276-7672    mducey@stamhealth.org   
Principal Investigator: Ofer Wellisch, MD, MPH         
United States, District of Columbia
International Spine,Pain and Performance Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Sidrah Sheirkh, MS, CR Manager    703-718-4282 ext 109    ssheirkh@isppcenter.com   
Principal Investigator: Mehul Desai, M.D.         
Sub-Investigator: Punheet Sayal, M.D.         
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.         
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: June 29, 2020
Last Verified: June 2020
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
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations