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PDN Post Market, Multicenter, Prospective, Global Clinical Study
NCT05301816 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE Spinal Cord Stimulator (SCS)
Study Locations (8)
Michigan
- Michigan Pain Specialists — Ann Arbor
- Henry Ford Health — West Bloomfield
Alaska
- Neuroversion, Inc. — Anchorage
Ohio
- Ohio State University Wexner Medical Center — Columbus
Oklahoma
- Clinical Investigations, LLC — Edmond
Oregon
- Columbia Pain Management — Milwaukie
Pennsylvania
- WellSpan Interventional Pain Specialists — York
Virginia
- Virginia Interventional Pain & Spine Centers — Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2028-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05301816
The ClinicalTrials.gov registry entry for NCT05301816 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 497 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nevro, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Neuropathy, Painful appearing as the primary indexed condition, and to 1 intervention — of which Spinal Cord Stimulator (SCS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05301816 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Michigan, Alaska, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05301816 about?
NCT05301816 is a clinical study titled "PDN Post Market, Multicenter, Prospective, Global Clinical Study". 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 d...
What is the current status of trial NCT05301816?
This trial is currently recruiting. It is a NA study. The enrollment target is 497 participants. The study started on 2022-07-05. Estimated completion is 2028-10.
What conditions does trial NCT05301816 study?
This clinical trial studies the following conditions: Diabetic Neuropathy, Painful. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05301816?
The interventions under investigation include: Spinal Cord Stimulator (SCS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05301816?
This trial is sponsored by Nevro, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05301816 being conducted?
This trial has 8 study locations across Alaska, Michigan, Ohio, Oklahoma, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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