Retrospective-Prospective PNS Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Curonix LLC
Study ID
NCT06845631
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PNS device, observational study, no intervention during study — DEVICE
    PNS device, observational study, no intervention during study

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Feb 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Observational
    observational

Primary Outcome Measure

Pain scores [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Metrohealth SystemClevelandOhio44109
Samantha Pope
[email protected]
216-778-1270
Brendan Astley, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Metrohealth System· Cleveland, OH

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