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Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs (Prodigy-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143791
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

Condition or disease Intervention/treatment
Chronic Pain Procedure: Burst stimulation Device: Prodigy system

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
Study Start Date : June 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Burst stimulation
At permanent implant with the Prodigy system, patients will be programmed with Burst stimulation
Procedure: Burst stimulation
Device: Prodigy system



Primary Outcome Measures :
  1. The primary endpoint is the percentage of pain relief at the 3-month visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Rate of serious adverse events (SAEs) and/or procedure/device-related adverse events ((S)ADEs) [ Time Frame: from enrollment to 12 months follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are indicated for Spinal Cord Stimulation (SCS) and with Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
Criteria

Inclusion Criteria:

  • Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
  • Patient is considered by the investigator as a candidate for implantation of a SCS system
  • Patient is ≥ 18 years of age
  • Patient must be willing and able to comply with study requirements
  • Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion Criteria:

  • Patient is immune-compromised
  • Patient has history of cancer requiring active treatment in the last 6 months
  • Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
  • Patients with a SCS system or implantable infusion pump implanted previously
  • Patient has a life expectancy of less than one year
  • Patient is pregnant or is planning to become pregnant during the duration of the investigation
  • Patient is unable to comply with the follow up schedule
  • Patient needing legally authorized representative
  • Patient unable to read and write
  • Patient is currently participating in another clinical investigation with an active treatment arm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143791


Locations
Show Show 21 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Tony Van Havenbergh St Augustinus, Wilrijk, Belgium
Study Director: Roni Diaz Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02143791    
Other Study ID Numbers: NM-13-038-ID-SC
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Keywords provided by Abbott Medical Devices:
SCS
Burst stimulation
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations