Pain
Conditions
Keywords
SCS, St. Jude Medical, Neuromodulation
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.
Interventions
DEVICESt. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Puerto Rico, United States
Outcome results
None listed