A Prospective Clinical Outcomes Registry (PAIN Registry)

This study is ongoing, but not recruiting participants.

Sponsor:

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

History of Changes

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

Show 32 Study Locations

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 18, 2013

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