Retrospective PNS Study

February 12, 2025 updated by: Curonix LLC

Retrospective Clinical Trial Investigating the Treatment of Chronic Pain with the Freedom Peripheral Nerve Stimulation System

Retrospective PNS Study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • Colorado Pain Care

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

200

Description

Inclusion Criteria:

A. Subjects are at least 18 years of age, B. Subjects have been diagnosed with refractory chronic pain, C. Subject has been implanted with a permanent Freedom Peripheral Nerve Stimulation System.

Exclusion Criteria:

A. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom Peripheral Nerve Stimulation System.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VRS
Time Frame: 36 months
A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health economic data
Time Frame: 12 months
The value of claims data at the site will be measured from 1 year before and up to the date of implant and compared to the claims value up to 1 year after implant. The number of appointments will be collected together with the CPT codes used for pain interventions.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curonix LLC

Collaborators

Colorado pain Care, LLC

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 Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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