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PDN Post Market, Multicenter, Prospective, Global Clinical Study
Sponsor: Nevro Corp
Summary
The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.
Official title: A Post-Market, Multicenter, Prospective, Global Clinical Study to Evaluate the Real-world Experience of Spinal Cord Stimulation That Includes 10 kHz in the Management of Chronic Intractable Pain Associated With Diabetic Neuropathy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
497
Start Date
2022-07-05
Completion Date
2028-10
Last Updated
2024-11-07
Healthy Volunteers
No
Conditions
Interventions
Spinal Cord Stimulator (SCS)
Spinal cord stimulation system (SCS) is an approved system to manage chronic intractable pain of the limbs and/or leg by delivering electrical stimulation using implantable leads and rechargeable implantable pulse generator (IPG) with 16 output channels. The IPG is implanted in a subcutaneous pocket and is capable of stimulating the spinal cord nerves when used with one or two 8-contact percutaneous or paddle leads.
Locations (8)
Neuroversion, Inc.
Anchorage, Alaska, United States
Michigan Pain Specialists
Ann Arbor, Michigan, United States
Henry Ford Health
West Bloomfield, Michigan, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Clinical Investigations, LLC
Edmond, Oklahoma, United States
Columbia Pain Management
Milwaukie, Oregon, United States
WellSpan Interventional Pain Specialists
York, Pennsylvania, United States
Virginia Interventional Pain & Spine Centers
Roanoke, Virginia, United States