NCT01305525CompletedNot Applicable
Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 614
- Primary Endpoint
- Patient reported outcomes over time
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has signed and received a copy of the Informed Consent form;
- •Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
- •Patient is 18 years of age or older.
- •Patient is not currently participating in another clinical trial.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patient reported outcomes over time
Time Frame: 2 years
The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
Secondary Outcomes
No secondary outcomes reported
Investigators
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