Actively Recruiting
Retrospective-Prospective PNS Study
Led by Curonix LLC · Updated on 2025-02-25
40
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
C
Curonix LLC
Lead Sponsor
M
MetroHealth System, Ohio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Retrospective-Prospective PNS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older at time of permanent implant
- Subject has been implanted with the Freedom Peripheral Nerve Stimulation system
- Subject is willing to attend scheduled visits and comply with study requirements (if prospective)
- Subject is capable of giving informed consent
You will not qualify if you...
- Subject is currently enrolled in or plans to enroll in any other drug or device study for chronic pain (if prospective)
- Subject has any additional active implanted devices for chronic pain treatment besides the Freedom PNS system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Metrohealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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