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Neurostimulation Device
PNS Device for Chronic Pain
Cleveland, OH
N/A
Recruiting
Research Sponsored by Curonix LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥ 18 years of age at time permanent implant
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effectiveness of a permanent Freedom PNS System in treating chronic, severe pain that has not responded to traditional treatments. They will look at the medical records of 40 patients who
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Who is the study for?
This trial is for individuals with chronic, intractable pain from peripheral nerve issues that haven't improved with standard treatments. Participants must have had the Freedom PNS System implanted for at least a year.Check my eligibility
What is being tested?
The study looks back at medical records and follows up on patients who received the Freedom PNS device to manage chronic pain. It's observational, meaning no new treatment is given during the study.See study design
What are the potential side effects?
Since this is an observational study reviewing past data of patients who already have the PNS device, it does not directly involve new side effects; however, general risks may include discomfort or complications related to having had the device implanted.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain scores
Secondary study objectives
Amount of sleep
Claims data
EQ-5D-5L
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ObservationalExperimental Treatment1 Intervention
observational
Find a Location
Closest Location:The Metrohealth System· Cleveland, OH
Who is running the clinical trial?
Curonix LLCLead Sponsor
8 Previous Clinical Trials
642 Total Patients Enrolled
2 Trials studying Chronic Pain
249 Patients Enrolled for Chronic Pain
MetroHealth System, OhioOTHER
7 Previous Clinical Trials
26,075 Total Patients Enrolled