A Prospective Clinical Outcomes Registry (PAIN Registry)

Abbott

Status: Completed

Conditions: Pain

Treatments: Device: St. Jude Medical Spinal Cord Stimulation Systems

Study type: Observational

Funder types: Industry

Identifiers

NCT01305525

C-09-01

Details and patient eligibility

About

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.

Enrollment: 614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

614 participants in 1 patient group

Spinal Cord Stimulation

Treatment:

Device: St. Jude Medical Spinal Cord Stimulation Systems