RecruitingNot ApplicableNCT05301816

PDN Post Market, Multicenter, Prospective, Global Clinical Study

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.


Sponsor

Nevro Corp

Enrollment

497 participants

Start Date

Jul 5, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Spinal Cord Stimulator (SCS) for people with diabetic neuropathy, painful. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpinal 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

View Full Details on ClinicalTrials.gov

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NCT05301816


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