A Prospective Clinical Outcomes Registry (PAIN Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:
NCT01305525
First received: February 25, 2011
Last updated: April 23, 2014
Last verified: April 2014

February 25, 2011
April 23, 2014
June 2009
April 2014   (final data collection date for primary outcome measure)
Patient reported outcomes over time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
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Complete list of historical versions of study NCT01305525 on ClinicalTrials.gov Archive Site
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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.

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Observational
Time Perspective: Prospective
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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
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*   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:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01305525
C-09-01
No
Advanced Neuromodulation Systems
Advanced Neuromodulation Systems
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Advanced Neuromodulation Systems
April 2014

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