A Prospective Clinical Outcomes Registry

NCT ID: NCT01305525

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal Cord Stimulation

St. Jude Medical Spinal Cord Stimulation Systems

Intervention Type DEVICE

Spinal cord stimulation

Interventions

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St. Jude Medical Spinal Cord Stimulation Systems

Spinal cord stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scottsdale, Arizona, United States

Site Status

Azusa, California, United States

Site Status

Chula Vista, California, United States

Site Status

Sacramento, California, United States

Site Status

Jacksonville, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Evansville, Indiana, United States

Site Status

Muncie, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Baton Rouge, Louisiana, United States

Site Status

Bloomfield Hills, Michigan, United States

Site Status

Waterford, Michigan, United States

Site Status

Saint Paul, Minnesota, United States

Site Status

Kalispell, Montana, United States

Site Status

New York, New York, United States

Site Status

Syracuse, New York, United States

Site Status

Utica, New York, United States

Site Status

Williamsville, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Mansfield, Ohio, United States

Site Status

Purcell, Oklahoma, United States

Site Status

Bethlehem, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

Southlake, Texas, United States

Site Status

Webster, Texas, United States

Site Status

Arlington, Virginia, United States

Site Status

Edmonds, Washington, United States

Site Status

Kirkland, Washington, United States

Site Status

Charleston, West Virginia, United States

Site Status

Morgantown, West Virginia, United States

Site Status

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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C-09-01

Identifier Type: -

Identifier Source: org_study_id

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