NCT06845631

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
6mo left

Started Jul 2024

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 11, 2025

Last Update Submit

February 24, 2025

Conditions

Chronic Pain

Keywords

chronic pain, PNS, Retrospective, prospective

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.

    12 months

Secondary Outcomes (7)

  • Opioids

    12 months

  • Work status

    12 months

  • GPES

    12 months

  • Amount of sleep

    12 months

  • Sleep disturbances

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Observational

EXPERIMENTAL

observational

Device: PNS device, observational study, no intervention during study

Interventions

PNS device, observational study, no intervention during studyDEVICE

PNS device, observational study, no intervention during study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Metrohealth System

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Observation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Retrospective/Prospective
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 25, 2025

Study Start

July 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

US(1)