RECRUITING

PDN Post Market, Multicenter, Prospective, Global Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2022-07-05
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05301816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kerry Bradley
CONTACT
1-650-251-0005
bradley@nevro.com
Manish Bharara, PhD
CONTACT
1 (650) 785 1061
manish.bharara@nevro.com

Principal Investigator

David Caraway, MD
STUDY_DIRECTOR
Chief Medical Officer, Nevro Corp

Study Locations (Sites)

Neuroversion, Inc.
Anchorage, Alaska, 99508
United States
Michigan Pain Specialists
Ann Arbor, Michigan, 48108
United States
Henry Ford Health
West Bloomfield, Michigan, 48322
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
United States
Columbia Pain Management
Milwaukie, Oregon, 97222
United States
WellSpan Interventional Pain Specialists
York, Pennsylvania, 17402
United States
Virginia Interventional Pain & Spine Centers
Roanoke, Virginia, 24018
United States

Collaborators and Investigators

Sponsor: Nevro Corp

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-05
Study Completion Date2028-10

Study Record Updates

Study Start Date2022-07-05
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Stimulation (SCS)

Additional Relevant MeSH Terms

  • Diabetic Neuropathy, Painful