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

Chronic Pain Clinical Trial

— RESCUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643213
• Other study ID #: A7006
• Secondary ID: A7006
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: February 2015

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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 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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Non Boston Scientific SCS Trial Therapy
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/ OMG
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

Locations

Country	Name	City	State
United States	Coastal Orthopedics and Sports Medicine of Southwest Florida, PA	Bradenton	Florida
United States	Comprehensive Pain Specialists	Broomfield	Colorado
United States	Rush University Medical Center	Chicago	Illinois
United States	Riverhills Healthcare Incorporated	Cincinnati	Ohio
United States	Columbia Interventional Pain Center	Columbia	Missouri
United States	Global Scientific Innovations - Advanced Pain Care Clinic	Evansville	Indiana
United States	Southeastern Integrated Medical	Gainesville	Florida
United States	Southern New York NeuroSurgical Group	Johnson City	New York
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Neurovations	Napa	California
United States	New York Spine and Wellness Center	North Syracuse	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Hope Research Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's Treatment Preference	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	30 minutes after activation of stimulation