RecruitingNot ApplicableNCT06845631

Retrospective-Prospective PNS Study

Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System


Sponsor

Curonix LLC

Enrollment

40 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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Interventions

DEVICEPNS device, observational study, no intervention during study

PNS device, observational study, no intervention during study


Locations(1)

The Metrohealth System

Cleveland, Ohio, United States

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NCT06845631


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