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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01643213
• Collaborator: (none)
• Enrollment: 27
• Locations: 13
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Non Boston Scientific SCS Trial Therapy; Device: BSC approved SCS Trial Therapy w/ OMG	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BSC approved SCS Trial Therapy w/ OMG Precision 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)	Device: 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
Active Comparator: Non Boston Scientific SCS Trial Therapy Non 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	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

Outcome Measures

Primary Outcome Measures

1. Subject's Treatment Preference [30 minutes after activation of stimulation]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hope Research Institute	Phoenix	Arizona	United States	85018
2	Neurovations	Napa	California	United States	94558
3	Comprehensive Pain Specialists	Broomfield	Colorado	United States	80020
4	Coastal Orthopedics and Sports Medicine of Southwest Florida, PA	Bradenton	Florida	United States	34209
5	Southeastern Integrated Medical	Gainesville	Florida	United States	32607
6	Compass Research, LLC	Orlando	Florida	United States	32806
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	Global Scientific Innovations - Advanced Pain Care Clinic	Evansville	Indiana	United States	47714
9	Columbia Interventional Pain Center	Columbia	Missouri	United States	65201
10	Southern New York NeuroSurgical Group	Johnson City	New York	United States	13790
11	New York Spine and Wellness Center	North Syracuse	New York	United States	13212
12	Riverhills Healthcare Incorporated	Cincinnati	Ohio	United States	45242
13	West Virginia University Hospitals	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01643213
• Other Study ID Numbers: A7006; A7006
• First Posted: Jul 18, 2012
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Treatment to Control	Control to Treatment
Arm/Group Description	Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)	Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
Period Title: Overall Study
STARTED	13	14
COMPLETED	12	14
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Treatment to Control	Control to Treatment	Total
Arm/Group Description	Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)	Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)	Total of all reporting groups
Overall Participants	13	14	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (11.71)	56 (12.02)	56.9 (11.68)
Sex: Female, Male (Count of Participants)
Female	7 53.8%	3 21.4%	10 37%
Male	6 46.2%	11 78.6%	17 63%
Region of Enrollment: United States (participants) [Number]
Number [participants]	13 100%	14 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Subject's Treatment Preference
Description	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
Time Frame	30 minutes after activation of stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment to Control	Control to Treatment
Arm/Group Description	Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)	Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
Measure Participants	12	13
Period 1 Yes, Period 2 Yes	6 46.2%	3 21.4%
Period 1 Yes, Period 2 No	1 7.7%	2 14.3%
Period 1 No, Period 2 Yes	1 7.7%	4 28.6%
Period 1 No, Period 2 No	4 30.8%	4 28.6%

Adverse Events

Time Frame	180 days post randomization
Arm/Group Title	Treatment to Control		Control to Treatment
Arm/Group Description	Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)		Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
All Cause Mortality
	Treatment to Control		Control to Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment to Control		Control to Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Treatment to Control		Control to Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.