Study on the Freedom PNS System for chronic pain relief
Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System
This study is testing whether the Freedom PNS System can help people with long-lasting nerve pain feel better after having the device for a year or more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Curonix LLC Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06845631 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Freedom PNS System in patients suffering from chronic, intractable pain of peripheral nerve origin. It involves a retrospective chart review of 40 patients who have had the device implanted for at least 12 months, assessing their baseline and follow-up parameters. The study aims to gather data on the long-term outcomes of this treatment approach, with the potential to collect additional data after obtaining informed consent from participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been implanted with the Freedom PNS system and are willing to comply with study requirements.
Not a fit: Patients currently enrolled in other concurrent drug or device studies or those with additional active implanted devices for chronic pain will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the Freedom PNS System for managing chronic pain.
How similar studies have performed: While this study utilizes a retrospective-prospective approach, similar studies on peripheral nerve stimulation have shown promising results in managing chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- The Metrohealth System — Cleveland, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.