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Patient Retrospective Outcomes (PRO) (PRO)

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ClinicalTrials.gov Identifier: NCT01550575
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date March 5, 2012
First Posted Date March 12, 2012
Last Update Posted Date January 22, 2021
Actual Study Start Date April 3, 2012
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Retrospective Outcomes (PRO)
Official Title Patient Retrospective Outcomes (PRO)
Brief Summary This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.
Detailed Description

This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who have previously been implanted with, or who are candidates for implantation with a spinal cord stimulation system or other various treatment approaches, such as radio frequency ablation or indirect decompression system (IDS).
Condition Chronic Pain
Intervention
  • Device: Non Boston Scientific Systems
    Spinal cord stimulation, RF, IDS etc.
  • Device: Boston Scientific Systems
    Spinal cord stimulation, RF, IDS etc
Study Groups/Cohorts
  • Patients eligible for SCS, RF or other treatment approaches
    Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc.
    Interventions:
    • Device: Non Boston Scientific Systems
    • Device: Boston Scientific Systems
  • Patients Eligible for treatment options with prior treatment
    Patients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc.
    Interventions:
    • Device: Non Boston Scientific Systems
    • Device: Boston Scientific Systems
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 11, 2018)		 10000
Original Estimated Enrollment
 (submitted: March 7, 2012)		 2000
Estimated Study Completion Date December 2027
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key Inclusion Criteria:

  • Previously treated with or eligible for use with Boston Scientific Systems
  • 18 years of age or older at the start of Baseline
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diane Keesey (661) 949-4175 Diane.Keesey@bsci.com
Contact: Roshini Jain 469-766-9888 roshini.jain@bsci.com
Listed Location Countries Australia,   France,   Germany,   Italy,   Netherlands,   Puerto Rico,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550575
Other Study ID Numbers A7005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation
PRS Account Boston Scientific Corporation
Verification Date January 2021