Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector (RESCUE)
This study is currently recruiting participants.
Verified May 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01643213
First received: July 11, 2012
Last updated: May 30, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) Precision Plus™ spinal cord stimulation (SCS) system 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: Precision Plus 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: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Precision Plus 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 Precision Plus SCS system with the Observational Mechanical Gateway(OMG)to connect to non-BSC lead(s)
|
Device: Precision Plus SCS Trial Therapy w/ OMG
No procedures will be attempted as part of this study. This intervention refers to connection and activation of the FDA-approved Boston Scientific SCS trial system 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 Boston Scientific's Precision Plus™ ETS to evaluate Precision Plus™ 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
- 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
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: Valerie Lucero-CImmarusti | 661-949-4745 | Valerie.Cimmarusti@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: | Tamara Baynham, PhD | 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: | May 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013