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RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Recruiting
18 years of age
Both
Phase N/A

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Overview

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

  • and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Description

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Eligibility

Key Inclusion Criteria:

  • Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
  • Signed a valid, IRB/EC-approved informed consent form
  • 18 years of age or older

Key Exclusion Criteria:

  • Contraindicated for Boston Scientific neurostimulation system
  • Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Study details

Pain

NCT01719055

Boston Scientific Corporation

23 April 2025

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