Clinical Trials Study

N/A

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

Conditions: Pain

Study #:
NCT01719055
Last Updated:
05/11/2026
Recruitment Status:
Recruiting
Estimated Study Completion Date:
05/01/2035

Summary

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

Age: 18 Years and older

Gender: All

Start Date: 11/19/2012

Primary Completion Date (Estimated): 05/01/2035

Study Completion Date (Estimated): 05/01/2035

Accepts Healthy Volunteers: No

Trial Purpose and Description

The study is a prospective, multi-center, global, post-market study 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 Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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

Principal Investigator

Sayed Wahezi, MD

For more information about this study, contact:

Sayed Wahezi

swahezi@montefiore.org