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Sponsored by: |
Bioness Inc |
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Information provided by: | Bioness Inc |
ClinicalTrials.gov Identifier: | NCT00665132 |
This study is being done to see how well a new investigational medical device, the StimRouter System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
Condition | Intervention | Phase |
---|---|---|
Carpal Tunnel Syndrome Pain |
Device: StimRouter System |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves |
Estimated Enrollment: | 10 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
This is a prospective, single-center, open label study designed to evaluate the clinical use of the StimRouter as a peripheral nerve stimulation device for the treatment of chronic pain. The clinical study is proposed to serve as an evaluation of the preliminary StimRouter design, proposed implantation techniques, electrical stimulation parameters, and outcome measures for the StimRouter. The current study will utilize the median nerve (in the context of carpal tunnel syndrome (CTS), status-post a single failed carpal tunnel release (CTR) surgery)as a model to represent the device's more general intended use as a peripheral nerve stimulator to treat chronic pain.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charina Icamen-Curry | (661)362-6646 | charina.icamencurry@bioness.com |
United States, West Virginia | |
The Center for Pain Relief | Recruiting |
Charleston, West Virginia, United States, 25301 | |
Contact: Diana Bowne, RN 304-347-6193 diana.bowne@stfh.com | |
Principal Investigator: Timothy Deer, MD |
Study Director: | Evan L. Rosenfeld, MD, JD | Bioness Inc |
Responsible Party: | Bioness Development LLC ( Evan Rosenfeld, MD, JD ) |
Study ID Numbers: | CP-STMR07-001-Rev A.1 |
Study First Received: | April 21, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00665132 |
Health Authority: | United States: Institutional Review Board |
wrist hand pain failed CTR carpal tunnel syndrome |
CTS CTR carpel tunnel release Peripheral nerve Median nerve |
Carpal Tunnel Syndrome Roussy Levy hereditary areflexic dystasia Charcot-Marie-Tooth Disease Wounds and Injuries Disorders of Environmental Origin Pain Mononeuropathies Nerve Compression Syndromes |
Tomaculous neuropathy Neuromuscular Diseases Peripheral Nervous System Diseases Hereditary Motor and Sensory Neuropathies Charcot Marie Tooth disease Cumulative Trauma Disorders Sprains and Strains |
Median Neuropathy Pathologic Processes Disease Syndrome Nervous System Diseases |