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PDN Post Market, Multicenter, Prospective, Global Clinical Study

NCT05301816 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2024-11-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nevro Corp

    lead INDUSTRY

Principal Investigators

  • David Caraway, MD · Chief Medical Officer, Nevro Corp

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2027-10-31
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301816 on ClinicalTrials.gov