Clinical trial NCT04192591: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar Spinal Stenosis
LSS
Chronic Pain
Leg Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 166
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of success at the 24-month follow-up visit
timeFrame: 24-Months
Secondary outcomes:
measure: Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
timeFrame: 24-, 36-, 48- and 60-Months
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Coastal Research Institute, LLC
state: California
city: Larkspur
country: United States
facility: MarinHealth Spine Institute
state: California
city: Rancho Mirage
country: United States
facility: Vitamed Research
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Gainesville
country: United States
facility: The Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: Alliance Spine and Pain Centers
state: Georgia
city: Waycross
country: United States
facility: Centurion Spine and Pain
state: Georgia
city: Post Falls
country: United States
facility: North Idaho Day Surgery
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Ascension Alexian Brothers
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medical University
state: New York
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Murrells Inlet
country: United States
facility: SC Pain and Spine Specialists
state: South Carolina
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
city: Charleston
country: United States
facility: The Spine and Nerve Center of Saint Francis Hospital
state: West Virginia
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: