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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01643213
First received: July 11, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chronic Pain
Device: Non Boston Scientific SCS Trial Therapy
Device: All BSC commercially approved SCS Trial Therapy w/ OMG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Subject's treatment preference [ Time Frame: 30 minutes after activation of stimulation ] [ Designated as safety issue: No ]
    Subject will be 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


Secondary Outcome Measures:
  • Overall pain intensity and percent pain relief [ Time Frame: 30 minutes after activation of stimulation ] [ Designated as safety issue: No ]
  • Subject's clinical impression of change and satisfaction [ Time Frame: 30 minutes after activation of stimulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All BSC commercially approved SCS Trial Therapy w/ OMG
Precision Plus SCS Trial Therapy w/ OMG. Spinal cord stimulation (SCS) trial therapy will be activated using the FDA-approved BSC Spinal Cord Stimulation SCS trial systems with the Observational Mechanical Gateway(OMG)to connect to non-BSC lead(s)
Device: All BSC commercially 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
Active Comparator: Non Boston Scientific SCS Trial Therapy
Non Boston Scientific SCS Trial Therapy. Spinal cord stimulation (SCS) trial therapy will be activated using the FDA-approved non Boston Scientific Corporation SCS system that the subject was implanted with, and received SCS therapy from, prior to study enrollment
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643213

Contacts
Contact: Natalie Bloom Lyons, MA 763-228-9040 Natalie.BloomLyons@bsci.com
Contact: Diane Bowers 661-949-4175 Diane.Bowers@bsci.com

Locations
United States, California
Boston Scientific Clinical Research Information Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Roshini Jain Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01643213     History of Changes
Other Study ID Numbers: A7006, A7006
Study First Received: July 11, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2014