NCT05301816

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 497 (estimated)
• Sponsor: Nevro Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-05
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2022-03-31
• Last updated: 2024-11-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study