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NCT05301816 · ClinicalTrials.gov registry record · NA

PDN Post Market, Multicenter, Prospective, Global Clinical Study

A NA study of Diabetic Neuropathy, Painful, sponsored by Nevro.

Recruiting
Registry status
NA
Development phase
497
Enrollment target
8
Study locations

NCT05301816 is a NA study of Diabetic Neuropathy, Painful that is actively recruiting participants, run by Nevro. The registered enrollment target is 497 participants. The trial reports 8 study locations across 7 states.

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The verdict

NCT05301816, a NA study of Diabetic Neuropathy, Painful, is actively recruiting participants, sponsored by Nevro.

RECRUITING
Registry status
NA
Development phase
497 participants
Enrollment target
8
Study locations

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.

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

FieldValue
Enrollment Target 497 participants
Start Date 2022-07-05
Est. Completion 2028-10
Phase NA

Sponsor

Nevro

8 total trials

What the Registry Record Tells You About NCT05301816

The ClinicalTrials.gov registry entry for NCT05301816 describes a study currently listed as recruiting, categorized as NA. 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 8 total studies on file at ClinicalTrials.gov.

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.

NCT05301816 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Michigan, Alaska, Ohio.

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.

What interventions are being tested in trial NCT05301816?

The interventions under investigation include: Spinal Cord Stimulator (SCS) (DEVICE).

Who is sponsoring clinical trial NCT05301816?

This trial is sponsored by Nevro, which has 8 total clinical trials registered on ClinicalTrials.gov.

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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