A Prospective Clinical Outcomes Registry

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Juan, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

None

Treatment and study plan

St. Jude Medical Spinal Cord Stimulation Systems

Device

Spinal cord stimulation

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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry

Acronym: PAIN Registry

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Feb 28, 2011
Registry last updated: Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed