Recruiting

Observational StudyRetrospective-Prospective PNS Study

Sponsor:

Curonix LLC

Code:

NCT06845631

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PNS device, observational study, no intervention during study

Study Details

Brief 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

Chronic Pain

Study ID

NCT06845631

Start date

Jul 1, 2024

Status verified date

Feb, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Observational

observational

Interventions

PNS device, observational study, no intervention during study

Primary outcome measure

Pain scores [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

The Metrohealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Samantha Pope

216-778-1270 Spope1@metrohealth.org

Principal Investigator:

Brendan Astley, MD

More Information

Sponsor

Curonix LLC

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Keywords

chronic pain, PNS, Retrospective, prospective

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Curonix LLC on 2025-02-25.