A Prospective Clinical Outcomes Registry (PAIN Registry)
This study is ongoing, but not recruiting participants.
Sponsor:
Advanced Neuromodulation Systems
Information provided by (Responsible Party):
Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:
NCT01305525
First received: February 25, 2011
Last updated: October 9, 2012
Last verified: October 2012
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Purpose
This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.
Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.
| Condition | Intervention |
|---|---|
|
Pain |
Device: St. Jude Medical Spinal Cord Stimulation Systems |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry |
Further study details as provided by Advanced Neuromodulation Systems:
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Spinal Cord Stimulation |
Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients implanted with a neuromodulation system
Criteria
Inclusion Criteria:
- Patient has signed and received a copy of the Informed Consent form;
- Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
- Patient is 18 years of age or older.
- Patient is not currently participating in another clinical trial.
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305525
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Hide Study LocationsLocations
| United States, Arizona | |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Azusa, California, United States | |
| Chula Vista, California, United States | |
| Sacramento, California, United States | |
| United States, Florida | |
| Jacksonville, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Indiana | |
| Evansville, Indiana, United States | |
| Muncie, Indiana, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| Baton Rouge, Louisiana, United States | |
| United States, Michigan | |
| Bloomfield Hills, Michigan, United States | |
| Waterford, Michigan, United States | |
| United States, Minnesota | |
| St. Paul, Minnesota, United States | |
| United States, Montana | |
| Kalispell, Montana, United States | |
| United States, New York | |
| New York City, New York, United States | |
| Syracuse, New York, United States | |
| Utica, New York, United States | |
| Williamsville, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Mansfield, Ohio, United States | |
| United States, Oklahoma | |
| Purcell, Oklahoma, United States | |
| United States, Pennsylvania | |
| Bethlehem, Pennsylvania, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| Southlake, Texas, United States | |
| Webster, Texas, United States | |
| United States, Virginia | |
| Arlington, Virginia, United States | |
| United States, Washington | |
| Edmonds, Washington, United States | |
| Kirkland, Washington, United States | |
| United States, West Virginia | |
| Charleston, West Virginia, United States | |
| Morgantown, West Virginia, United States | |
| Puerto Rico | |
| San Juan, Puerto Rico | |
Sponsors and Collaborators
Advanced Neuromodulation Systems
More Information
No publications provided
| Responsible Party: | Advanced Neuromodulation Systems |
| ClinicalTrials.gov Identifier: | NCT01305525 History of Changes |
| Other Study ID Numbers: | C-09-01 |
| Study First Received: | February 25, 2011 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Advanced Neuromodulation Systems:
|
SCS St. Jude Medical Neuromodulation |
ClinicalTrials.gov processed this record on June 17, 2013