This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Prospective Clinical Outcomes Registry (PAIN Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01305525
First received: February 25, 2011
Last updated: July 24, 2015
Last verified: April 2014
February 25, 2011
July 24, 2015
June 2009
April 2014   (Final data collection date for primary outcome measure)
Patient reported outcomes over time [ Time Frame: 2 years ]
The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
Not Provided
Complete list of historical versions of study NCT01305525 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Prospective Clinical Outcomes Registry
Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients implanted with a neuromodulation system
Pain
Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation
Spinal Cord Stimulation
Intervention: Device: St. Jude Medical Spinal Cord Stimulation Systems
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
614
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient has signed and received a copy of the Informed Consent form;
  2. Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
  3. Patient is 18 years of age or older.
  4. Patient is not currently participating in another clinical trial.

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01305525
C-09-01
No
Not Provided
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP