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
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Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
Tracking Information | |||||||||
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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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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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 |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
10000 | ||||||||
Original Estimated Enrollment |
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:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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PRS Account | Boston Scientific Corporation | ||||||||
Verification Date | January 2021 |