Retrospective-Prospective PNS Study

Last updated: February 24, 2025
Sponsor: Curonix LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

PNS device, observational study, no intervention during study

Clinical Study ID

NCT06845631
P011
  • Ages > 18
  • All Genders

Study Summary

This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.

A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.

Exclusion

Exclusion Criteria:

A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: PNS device, observational study, no intervention during study
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • The Metrohealth System

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

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