Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Precision Retrospective Outcomes (PRO) (PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01550575
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.

Condition or disease Intervention/treatment
Chronic Pain Device: Non Boston Scientific Spinal Cord Stimulation System Device: Boston Scientific Spinal Cord Stimulation Systems Other: Non-spinal cord stimulation conventional medical management for 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 SCS outcomes in different subgroups


Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Precision Retrospective Outcomes (PRO)
Study Start Date : March 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
SCS-Eligible Patients
Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system
Device: Non Boston Scientific Spinal Cord Stimulation System
Spinal cord stimulation

Device: Boston Scientific Spinal Cord Stimulation Systems
spinal cord stimulation

Other: Non-spinal cord stimulation conventional medical management for chronic pain
May include chronic pain medication, interventional pain procedures, spine surgery, etc.

SCS-Eligible Patients with prior stimulation
Patients who have previously been implanted with an spinal cord stimulation system and have thereafter received a different spinal cord stimulation system
Device: Non Boston Scientific Spinal Cord Stimulation System
Spinal cord stimulation

Device: Boston Scientific Spinal Cord Stimulation Systems
spinal cord stimulation

Other: Non-spinal cord stimulation conventional medical management for chronic pain
May include chronic pain medication, interventional pain procedures, spine surgery, etc.





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Previously treated with or eligible for implantation with a spinal cord stimulation system
  • 18 years of age or older at the start of Baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550575


Contacts
Layout table for location contacts
Contact: Diane Keesey (661) 949-4175 Diane.Keesey@bsci.com
Contact: Roshini Jain 469-766-9888 roshini.jain@bsci.com

Locations
Layout table for location information
United States, California
Boston Scientific Clinical Research Information - Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Layout table for investigator information
Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation

Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01550575     History of Changes
Other Study ID Numbers: A7005
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms