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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: BSC approved SCS Trial Therapy w/ OMG; Device: Non Boston Scientific SCS Trial Therapy

• Registration Number: NCT01643213
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

Spinal cord stimulation (SCS) is an established therapy for the treatment of chronic pain of the trunk and/or limbs. Standard practice includes a screening trial, typically lasting from 3 days to 7 days or more, for both the physician and the patient to evaluate whether SCS therapy is appropriate for permanent implantation. Screening trial success (hereafter referred to as a trial) is often considered predictive of long-term success of the therapy, although that has never been definitively demonstrated.

Boston Scientific Corporation (BSC) developed the Observational Mechanical Gateway (OMG) connectors to allow patients who previously underwent an SCS trial using Medtronic or St Jude Medical leads, operating room cables (OR-cables), and external trial stimulators (ETSs), to be able to connect to BSC commercially approved Spinal Cord Stimulation (SCS) trial systems to evaluate the BSC SCS therapy in the physician office setting prior to removal of the non-BSC leads.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-05-05
• Results First Submitted QC: 2016-05-05
• Results First Posted: 2016-06-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Chronic intractable pain of the trunk and/or lower extremities
• History of trunk and/or lower extremity pain lasting at least 6 months
• Study candidate completed a spinal cord stimulation (SCS) trial of a FDA-approved non-Boston Scientific Corporation (non-BSC) system, exclusively for the treatment of chronic intractable pain of the trunk and/or lower extremities, that will not proceed to permanent implantation due to unsatisfactory treatment or in the physician's opinion received sub-optimal results
• Currently implanted with FDA-approved non-BSC SCS lead(s) exclusively in the thoracolumbar epidural space that are temporarily anchored for non-surgical removal at the termination of the screening trial period and which are approved for use with either the Observational Mechanical Gateway (OMG) A or OMG-M, per the OMG directions for use

Key

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Exclusion Criteria

• Primary source of pain is cancer-related, pelvic, visceral or angina
• Investigator-suspected gross lead migration during the non-BSC trial period which may preclude the study candidate from receiving adequate SCS therapy
• Study candidate reports <10% paresthesia coverage of overall pain while running the preferred stimulation settings on the non-BSC SCS system at the end of the non-BSC SCS screening trial period
• Study candidate unwilling to tolerate implantation with an SCS system

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BSC approved SCS Trial Therapy w/ OMG	BSC approved SCS Trial Therapy w/ OMG	Precision Plus SCS Trial Therapy w/ OMG. Spinal cord stimulation (SCS) trial therapy activated using FDA-approved BSC SCS trial systems with the Observational Mechanical Gateway(OMG) to connect to non-BSC lead(s)
Non Boston Scientific SCS Trial Therapy	Non Boston Scientific SCS Trial Therapy	Non Boston Scientific SCS Trial Therapy. Spinal cord stimulation (SCS) trial therapy activated using FDA-approved non BSC SCS system that the subject was implanted with, and received SCS therapy from, prior to study enrollment

Primary Outcome Measures

Name	Time	Method
Subject's Treatment Preference	30 minutes after activation of stimulation	Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline

Trial Locations

Locations (13)

Coastal Orthopedics and Sports Medicine of Southwest Florida, PA; 🇺🇸 Bradenton, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

West Virginia University Hospitals; 🇺🇸 Morgantown, West Virginia, United States

Neurovations; 🇺🇸 Napa, California, United States

Comprehensive Pain Specialists; 🇺🇸 Broomfield, Colorado, United States

Southern New York NeuroSurgical Group; 🇺🇸 Johnson City, New York, United States

Columbia Interventional Pain Center; 🇺🇸 Columbia, Missouri, United States

Global Scientific Innovations - Advanced Pain Care Clinic; 🇺🇸 Evansville, Indiana, United States

New York Spine and Wellness Center; 🇺🇸 North Syracuse, New York, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

Southeastern Integrated Medical; 🇺🇸 Gainesville, Florida, United States

Riverhills Healthcare Incorporated; 🇺🇸 Cincinnati, Ohio, United States