Overview

This trial has been completed.

Condition chronic pain
Treatments burst stimulation, prodigy system
Sponsor St. Jude Medical
Start date June 2014
End date October 2016
Trial size 126 participants
Trial identifier NCT02143791, NM-13-038-ID-SC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
At permanent implant with the Prodigy system, patients will be programmed with Burst stimulation
burst stimulation
prodigy system

Primary Outcomes

Measure
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 Outcomes

Measure
Rate of serious adverse events (SAEs) and/or procedure/device-related adverse events ((S)ADEs)
time frame: from enrollment to 12 months follow up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Tony Van Havenbergh
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.