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Clinical Trials/NCT05515341
NCT05515341
Recruiting
Not Applicable

A DirEct to PatieNt Study in Chronic Pain

Boston Scientific Corporation1 site in 1 country50,000 target enrollmentJanuary 10, 2023

Overview

Phase
Not Applicable
Intervention
Commercially Approved Interventional Medical Device/Therapy for Chronic Pain
Conditions
Chronic Pain
Sponsor
Boston Scientific Corporation
Enrollment
50000
Locations
1
Primary Endpoint
Change in pain post procedure
Status
Recruiting
Last Updated
26 days ago

Overview

Brief Summary

To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
December 1, 2029
Last Updated
26 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
  • Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
  • Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English

Exclusion Criteria

  • Requires a legal representative to sign the ICF ascertained from self-reporting

Arms & Interventions

Medical Device Therapy/Procedure for Chronic Pain

Intervention: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain

Outcomes

Primary Outcomes

Change in pain post procedure

Time Frame: up to 12 months

Change in patient-reported pain on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain

Study Sites (1)

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