NCT06845631NARecruiting

Retrospective-Prospective PNS Study

Curonix LLC

Start Date

7/1/2024

Completion Date

12/1/2026

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

Age Range: 18 years to No maximum

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 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.

Interventions

DEVICE

PNS device, observational study, no intervention during study

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Conditions

Chronic Pain

Locations

The Metrohealth System

Cleveland, Ohio 44109

United States