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RECRUITING
NCT05301816
NA

PDN Post Market, Multicenter, Prospective, Global Clinical Study

Sponsor: Nevro Corp

View on ClinicalTrials.gov

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

Interventions

DEVICE

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