NCT06832449

Brief Summary

Retrospective PNS Study

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 11, 2025

Last Update Submit

February 12, 2025

Conditions

Chronic Pain

Keywords

Retrospective, chronic pain, PNS

Outcome Measures

Primary Outcomes (1)

  • VRS

    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.

    36 months

Secondary Outcomes (1)

  • Health economic data

    12 months

Interventions

PNSDEVICE

Retrospective study investigating PNS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200

You may qualify if:

  • A. Subjects are at least 18 years of age, B. Subjects have been diagnosed with refractory chronic pain, C. Subject has been implanted with a permanent Freedom Peripheral Nerve Stimulation System.

You may not qualify if:

  • A. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom Peripheral Nerve Stimulation System.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Pain Care

Denver, Colorado, 80222, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 18, 2025

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

US(1)