CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Non Boston Scientific SCS Trial Therapy +1 moredevice
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.

Search/NCT01643213
NCT01643213N/ACompleted
CompareCT.gov

Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

Boston Scientific Corporation·interventional·Posted Jul 18, 2012·Updated Nov 13, 2020

In Brief

A clinical study evaluating Non Boston Scientific SCS Trial Therapy and BSC approved SCS Trial Therapy w/ OMG for Chronic Pain. Completed, enrolled 27 participants across 13 sites.

Detailed Summary

The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2012
Enrollment StartJul 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.0 years ago

Interventions

Non Boston Scientific SCS Trial Therapydevice

No procedures will be attempted as part of this study. This intervention refers to connection and activation of a previously implanted and programmed FDA-approved non Boston Scientific SCS trial system for 30 minutes of SCS therapy for pain

BSC approved SCS Trial Therapy w/ OMGdevice

No procedures will be attempted as part of this study. This intervention refers to connection and activation of all Boston Scientific commercially approved SCS trial systems for 30 minutes of SCS therapy for pain