Recruiting

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

Sponsor:

Boston Scientific Corporation

Code:

NCT01719055

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

neurostimulation system

Study Details

Brief 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

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

Conditions

Pain

Study ID

NCT01719055

Start date

Nov 19, 2012

Status verified date

Aug, 2026

Completion date

May, 2035

Anticipated

Primary completion date

May, 2035

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4800 participants

Anticipated

Interventions and Outcome Measures

Arms

Boston Scientific SCS Systems

Subjects permanently implanted with a Boston Scientific neurostimulation systems

Interventions

neurostimulation system

Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome

Central Contacts and Locations

Central contacts

Thanh Hoang, MS

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information