Back to resultsA 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Primary Purpose
Lumbar Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superion™ IDS device
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain
Eligibility Criteria
Key Inclusion Criteria:
- 45 years of age or older when written informed consent is obtained
- Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
- Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
- Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
- Able to independently read and complete all questionnaires and assessments provided in English
Key Exclusion Criteria:
- Axial back pain only.
- Fixed motor deficit in lower extremity(ies) due to LSS.
- Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor)
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Sites / Locations
- Coastal Research Institute, LLC
- Vitamed ResearchRecruiting
- Pacific Research Institute
- IPM Medical Group Inc.Recruiting
- Holy Cross HospitalRecruiting
- The Orthopaedic InstituteRecruiting
- Florida Pain Management
- Alliance Spine and Pain CentersRecruiting
- Centurion Spine and Pain
- North Idaho Day SurgeryRecruiting
- Rush University Medical CenterRecruiting
- Alexian Brothers Medical CenterRecruiting
- University of Kansas HospitalRecruiting
- Neuroscience Research Center, LLCRecruiting
- Brigham and Women's HospitalRecruiting
- Forest Health Medical CenterRecruiting
- Weill Cornell Medical UniversityRecruiting
- Pacific Sports and Spine, LLCRecruiting
- Center for Interventional Pain and SpineRecruiting
- SC Pain and Spine SpecialistsRecruiting
- Central Texas Pain Institute
- Precision Spine CareRecruiting
- Swedish Health ServicesRecruiting
- Northwest Pain Care
- The Spine and Nerve Center of Saint Francis HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Superion™ IDS device
Arm Description
Superion™ Indirect Decompression System (IDS)
Outcomes
Primary Outcome Measures
Rate of success at the 24-month follow-up visit
Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:
Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ
≥ 0.5-point improvement in physical function
≥ 0.5-point improvement in symptom severity
≤ 2.5 point on patient satisfaction domain
No reoperations, removals, revisions, or supplemental fixation at the index level(s)
No major implant or procedure-related complications
no dislodgement, migration, or device deformation
no new or persistent worsened neurological deficit at the index level†
no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months
Secondary Outcome Measures
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale
Full Information
NCT ID
NCT04192591
First Posted
December 6, 2019
Last Updated
October 9, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04192591
Brief Title
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Official Title
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
May 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed Description
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Superion™ IDS device
Arm Type
Experimental
Arm Description
Superion™ Indirect Decompression System (IDS)
Intervention Type
Device
Intervention Name(s)
Superion™ IDS device
Intervention Description
The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.
Primary Outcome Measure Information:
Title
Rate of success at the 24-month follow-up visit
Description
Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:
Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ
≥ 0.5-point improvement in physical function
≥ 0.5-point improvement in symptom severity
≤ 2.5 point on patient satisfaction domain
No reoperations, removals, revisions, or supplemental fixation at the index level(s)
No major implant or procedure-related complications
no dislodgement, migration, or device deformation
no new or persistent worsened neurological deficit at the index level†
no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months
Time Frame
24-Months
Secondary Outcome Measure Information:
Title
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
Description
Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale
Time Frame
24-, 36-, 48- and 60-Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
45 years of age or older when written informed consent is obtained
Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
Able to independently read and complete all questionnaires and assessments provided in English
Key Exclusion Criteria:
Axial back pain only.
Fixed motor deficit in lower extremity(ies) due to LSS.
Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor)
Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Yamano
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Research Institute, LLC
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Vitamed Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Pacific Research Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
IPM Medical Group Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
The Orthopaedic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Florida Pain Management
City
Sebastian
State/Province
Florida
ZIP/Postal Code
32958
Country
United States
Individual Site Status
Withdrawn
Facility Name
Alliance Spine and Pain Centers
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research R Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Centurion Spine and Pain
City
Waycross
State/Province
Georgia
ZIP/Postal Code
31501
Country
United States
Individual Site Status
Terminated
Facility Name
North Idaho Day Surgery
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
North IS Center
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Neuroscience Research Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
8552139890
Email
BSNClinicalTrials@bsci.com
Facility Name
Weill Cornell Medical University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Center for Interventional Pain and Spine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
SC Pain and Spine Specialists
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Central Texas Pain Institute
City
Killeen
State/Province
Texas
ZIP/Postal Code
76542
Country
United States
Individual Site Status
Withdrawn
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Northwest Pain Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Individual Site Status
Terminated
Facility Name
The Spine and Nerve Center of Saint Francis Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.vertiflexstudy.com/
Description
The SCOPE Study for Spinal Stenosis (vertiflexstudy.com)
Learn more about this trial
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
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