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
  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:

Primary Outcome Measures:
  • 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.


Enrollment: 614
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305525

  Hide Study Locations
Locations
United States, Arizona
Scottsdale, Arizona, United States
United States, California
Azusa, California, United States
Chula Vista, California, United States
Sacramento, California, United States
United States, Florida
Jacksonville, Florida, United States
Tampa, Florida, United States
United States, Indiana
Evansville, Indiana, United States
Muncie, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Michigan
Bloomfield Hills, Michigan, United States
Waterford, Michigan, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Montana
Kalispell, Montana, United States
United States, New York
New York City, New York, United States
Syracuse, New York, United States
Utica, New York, United States
Williamsville, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Mansfield, Ohio, United States
United States, Oklahoma
Purcell, Oklahoma, United States
United States, Pennsylvania
Bethlehem, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
Southlake, Texas, United States
Webster, Texas, United States
United States, Virginia
Arlington, Virginia, United States
United States, Washington
Edmonds, Washington, United States
Kirkland, Washington, United States
United States, West Virginia
Charleston, West Virginia, United States
Morgantown, West Virginia, United States
Puerto Rico
San Juan, Puerto Rico
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: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Advanced Neuromodulation Systems:
SCS
St. Jude Medical
Neuromodulation

ClinicalTrials.gov processed this record on September 22, 2014