Retrospective-Prospective PNS Study
NCT06845631 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-02-25
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.
Conditions
Interventions
- DEVICE
-
PNS device, observational study, no intervention during study
PNS device, observational study, no intervention during study
Sponsors & Collaborators
-
MetroHealth System, Ohio
collaborator OTHER -
Curonix LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2025-12-01
- Completion
- 2026-12-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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