A Prospective Clinical Outcomes Registry

Completed

• Conditions: Pain
• Interventions: Device: St. Jude Medical Spinal Cord Stimulation Systems

• Registration Number: NCT01305525
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	St. Jude Medical Spinal Cord Stimulation Systems	-

Primary Outcome Measures

Name	Time	Method
Patient reported outcomes over time	2 years	The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.