CClinicalTrials.gg
CompletedNCT01305525PAIN RegistryUpdated Jan 30, 2019

A Prospective Clinical Outcomes Registry

An observational study in Pain, sponsored by Abbott Medical Devices. Completed at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
614
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • SCS
  • St. Jude Medical
  • Neuromodulation
03

In context

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients implanted with a neuromodulation system

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
614 participants (actual)

Groups and cohorts

  • Spinal Cord Stimulation

    Device: St. Jude Medical Spinal Cord Stimulation Systems

Interventions

  • DeviceSt. Jude Medical Spinal Cord Stimulation Systems

    Spinal cord stimulation

06

What researchers measure

Primary outcomes

  1. Patient reported outcomes over time

    The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.

    Time frame: 2 years

07

Study locations

32 sites
  • Scottsdale, Arizona, United States
  • Azusa, California, United States
  • Chula Vista, California, United States
  • Sacramento, California, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Evansville, Indiana, United States
  • Muncie, Indiana, United States
  • Louisville, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Bloomfield Hills, Michigan, United States
  • Waterford, Michigan, United States
  • Saint Paul, Minnesota, United States
  • Kalispell, Montana, United States
  • New York, New York, United States
  • Syracuse, New York, United States
  • Utica, New York, United States
  • Williamsville, New York, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Mansfield, Ohio, United States
  • Purcell, Oklahoma, United States
  • Bethlehem, Pennsylvania, United States
  • Houston, Texas, United States
  • Southlake, Texas, United States
  • Webster, Texas, United States
  • Arlington, Virginia, United States
  • Edmonds, Washington, United States
  • Kirkland, Washington, United States
  • Charleston, West Virginia, United States
  • Morgantown, West Virginia, United States
  • San Juan, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01305525
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Feb 28, 2011
Start date
Jun 2009
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jan 30, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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