A Prospective Clinical Outcomes Registry

Completed

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01305525

Run by

Abbott Medical Devices

People needed

614

Starts

2009-06-01

Expected to finish

2014-04-01

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Azusa, California, United States
• Study site — Chula Vista, California, United States
• Study site — Sacramento, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Evansville, Indiana, United States
• Study site — Muncie, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Bloomfield Hills, Michigan, United States
• Study site — Waterford, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Kalispell, Montana, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Utica, New York, United States
• Study site — Williamsville, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Mansfield, Ohio, United States
• Study site — Purcell, Oklahoma, United States
• Study site — Bethlehem, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Southlake, Texas, United States

Full record on ClinicalTrials.gov

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