At a glance
ClinicalIndex Comparison RecordN/ACompleted· 126 enrolled
Drug / intervention
Burst and Tonic stimulationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating Burst and Tonic stimulation for Chronic Pain. Completed, enrolled 126 participants across 21 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesAustralia, Belgium, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJun 2014
Primary CompletionJan 2016
Study CompletionOct 2016
TodayJul 2026
First PostedMay 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionJan 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago
Interventions
Burst and Tonic stimulationprocedure