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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01719055




Registration number
NCT01719055
Ethics application status
Date submitted
30/10/2012
Date registered
1/11/2012
Date last updated
17/10/2024

Titles & IDs
Public title
RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Scientific title
A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Secondary ID [1] 0 0
90876777
Secondary ID [2] 0 0
A7007
Universal Trial Number (UTN)
Trial acronym
RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - neurostimulation system

Boston Scientific SCS Systems - Subjects permanently implanted with a Boston Scientific neurostimulation systems


Treatment: Devices: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2035
Actual
Sample size
Target
4800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Interventus Pain Specialists - Auchenflower
Recruitment hospital [2] 0 0
Hunter Clinical Research - Broadmeadow
Recruitment hospital [3] 0 0
Hunter Pain Clinic - Broadmeadow
Recruitment hospital [4] 0 0
Green Lizard Science - Claremont
Recruitment hospital [5] 0 0
Sydney Spine and Pain Pty Ltd - Hurstville
Recruitment hospital [6] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [7] 0 0
Pain Matrix - Waurn Ponds
Recruitment hospital [8] 0 0
Pain Medicine of South Australia - Wayville
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Broadmeadow
Recruitment postcode(s) [3] 0 0
- Claremont
Recruitment postcode(s) [4] 0 0
- Hurstville
Recruitment postcode(s) [5] 0 0
- Noosa Heads
Recruitment postcode(s) [6] 0 0
- Waurn Ponds
Recruitment postcode(s) [7] 0 0
- Wayville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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Texas
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Washington
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West Virginia
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Wisconsin
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Argentina
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Ciudad Autonoma de Buenos Aires
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Belgium
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Gent
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Belgium
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Roeselare
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Canada
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London
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Canada
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Québec
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Canada
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Regina
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Colombia
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Cali
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Colombia
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Floridablanca
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Denmark
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Odense
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Duesseldorf
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Germany
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Koeln
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Germany
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Köln
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Germany
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München
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Pavia
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Italy
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Pisa
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Japan
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Kobe-shi
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Japan
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Nishinomiya-shi
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Japan
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Okayama-shi
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Japan
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Sakai-shi
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Netherlands
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Velp
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Spain
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Ciudad Real
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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San Sebastián
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Spain
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Santander
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Spain
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Toledo
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Spain
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Valencia
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Sweden
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Göteborg
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Switzerland
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Viganello
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United Kingdom
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Basildon
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United Kingdom
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Bristol
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
State/province [61] 0 0
Stanmore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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 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
Trial website
https://clinicaltrials.gov/study/NCT01719055
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Bloom Lyons
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thanh Hoang, MS
Address 0 0
Country 0 0
Phone 0 0
855-213-9890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01719055