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
  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:

  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
  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 April 16, 2014