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Recruiting NCT01719055

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

Conditions: Pain

Sponsor: Boston Scientific Corporation

trial.available_in: БГ
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 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
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.
Who can participate
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
Locations 14
Argentina (1)
CENIT Centro de Neurociencias, Investigacion y Tratamiento
Buenos Aires
TERMINATED
Australia (1)
Interventus Pain Specialists
Auchenflower
WITHDRAWN
Belgium (1)
AZ Sint-Lucas
Ghent
WITHDRAWN
Canada (1)
London Health Sciences Centre
London
TERMINATED
Colombia (1)
Fundacion Clinica Valle del Lili
Cali
WITHDRAWN
Denmark (1)
Odense University Hospital
Odense
TERMINATED
Israel (1)
Sheba Medical Center
Ramat Gan
TERMINATED
Italy (1)
Fondazione Salvatore Maugeri IRCCS
Pavia
Boston Scientific Clinical Research Manager
Japan (1)
Kobe University Hospital
Kobe
TERMINATED
Netherlands (1)
Ziekenhuis Rijnstate
Velp
TERMINATED
Spain (1)
Hospital General de Ciudad Real
Ciudad Real
Boston Scientific Clinical Research
Sweden (1)
Sahlgrenska University Hospital
Gothenburg
TERMINATED
United Kingdom (1)
Basildon and Thurrock University Hospitals NHS
Basildon
Boston Scientific Clinical Research Manager
United States (1)
Physicians Research Group, LLC
Phoenix , Arizona
TERMINATED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
19.11.2012
Completion date
01.05.2035
Registry ID
NCT01719055
Source
anzctr
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