Clinical trial NCT01643213: Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
Official title: Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Subject's Treatment Preference
timeFrame: 30 minutes after activation of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Napa
country: United States
facility: Neurovations
state: California
city: Broomfield
country: United States
facility: Comprehensive Pain Specialists
state: Colorado
city: Bradenton
country: United States
facility: Coastal Orthopedics and Sports Medicine of Southwest Florida, PA
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evansville
country: United States
facility: Global Scientific Innovations - Advanced Pain Care Clinic
state: Indiana
city: Columbia
country: United States
facility: Columbia Interventional Pain Center
state: Missouri
city: Johnson City
country: United States
facility: Southern New York NeuroSurgical Group
state: New York
city: North Syracuse
country: United States
facility: New York Spine and Wellness Center
state: New York
city: Cincinnati
country: United States
facility: Riverhills Healthcare Incorporated
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
affiliation: Boston Scientific Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References: