Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
RESCUE
1 other identifier
interventional
27
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Jul 2012
Typical duration for not_applicable chronic-pain
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
June 13, 2016
CompletedNovember 13, 2020
November 1, 2020
2.6 years
July 11, 2012
May 5, 2016
November 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
BSC approved SCS Trial Therapy w/ OMG
EXPERIMENTALPrecision 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
ACTIVE COMPARATORNon 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Hope Research Institute
Phoenix, Arizona, 85018, United States
Neurovations
Napa, California, 94558, United States
Comprehensive Pain Specialists
Broomfield, Colorado, 80020, United States
Coastal Orthopedics and Sports Medicine of Southwest Florida, PA
Bradenton, Florida, 34209, United States
Southeastern Integrated Medical
Gainesville, Florida, 32607, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Global Scientific Innovations - Advanced Pain Care Clinic
Evansville, Indiana, 47714, United States
Columbia Interventional Pain Center
Columbia, Missouri, 65201, United States
Southern New York NeuroSurgical Group
Johnson City, New York, 13790, United States
New York Spine and Wellness Center
North Syracuse, New York, 13212, United States
Riverhills Healthcare Incorporated
Cincinnati, Ohio, 45242, United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Information
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Roshini Jain
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2012
First Posted
July 18, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 13, 2020
Results First Posted
June 13, 2016
Record last verified: 2020-11