A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Lumbar Spinal Stenosis Clinical Trial

Official title:

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192591
• Other study ID #: A4082
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: May 2032

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Ann Yamano
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Description:

To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: May 2032
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Superion™ IDS device
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.

Locations

Country	Name	City	State
United States	Alliance Spine and Pain Centers	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Coastal Research Institute, LLC	Carlsbad	California
United States	The Spine and Nerve Center of Saint Francis Hospital	Charleston	West Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Ascension Alexian Brothers	Elk Grove Village	Illinois
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	The Orthopaedic Institute	Gainesville	Florida
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Central Texas Pain Institute	Killeen	Texas
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	SC Pain and Spine Specialists	Murrells Inlet	South Carolina
United States	Weill Cornell Medical University	New York	New York
United States	Neuroscience Research Center, LLC	Overland Park	Kansas
United States	North Idaho Day Surgery	Post Falls	Idaho
United States	Vitamed Research	Rancho Mirage	California
United States	Pacific Research Institute	Santa Rosa	California
United States	Swedish Health Services	Seattle	Washington
United States	Florida Pain Management	Sebastian	Florida
United States	Northwest Pain Care	Spokane	Washington
United States	Spinal Diagnostics	Tualatin	Oregon
United States	Precision Spine Care	Tyler	Texas
United States	IPM Medical Group Inc.	Walnut Creek	California
United States	Centurion Spine and Pain	Waycross	Georgia
United States	Forest Health Medical Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24-Months
Secondary	Patient Satisfaction: VertiFlex® Patient Satisfaction Survey	Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring =3 on a 4-point scale	24-, 36-, 48- and 60-Months