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PDN Post Market, Multicenter, Prospective, Global Clinical Study

Study acronym: PDN-PM
StatusActive, Not Recruiting
PhaseNot applicable
SponsorNevro Corp
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v5
  2. Notable Primary completion date: Oct 2026 to Oct 2027
    • Study sites: 7 to 8
    • Study completion date: Mar 2027 to Oct 2028
    v4
  3. Notable Primary completion date: Oct 2024 to Oct 2026
    • Study sites: 6 to 7
    • Study completion date: Mar 2026 to Mar 2027
    • Start date changed from estimate of Jul 2022 to Jul 5, 2022
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2022 to Jul 2022
    • Study sites: 1 to 6
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT05301816
Lead Sponsor Nevro Corp
Conditions
(from sponsor)
Diabetic Neuropathy, Painful
Related terms Diabetic Neuropathies
Enrollment 497 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov