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

• ClinicalTrials.gov Identifier: NCT04192591
• Recruitment Status: Recruiting
• First Posted: December 10, 2019
• Last Update Posted: February 10, 2020
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Lumbar Spinal Stenosis	Device: Superion® IDS device	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 214 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 5-year Superion® IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
• Actual Study Start Date: January 30, 2020
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: January 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Superion® IDS device; Superion® Indirect Decompression System (IDS)	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.

Outcome Measures

Primary Outcome Measures :

1. Rate of success at the 24-month follow-up visit [ Time Frame: 24-Months ]

   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:

   1. 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
   2. No reoperations, removals, revisions, or supplemental fixation at the index level(s)

   3. 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 :

1. Patient Satisfaction: VertiFlex® Patient Satisfaction Survey [ Time Frame: 24-, 36-, 48- and 60-Months ]
   Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Natalie Bloom Lyons; 7632289040 ext 7632289040; lyonsn@bsci.com

Contact: Diane Keesey; 661-949-4175; diane.keesey@bsci.com

Locations

United States, California

Boston Scientific Clinical Research; Recruiting

Valencia, California, United States, 91355

Contact: Boston Scientific

Contact 855-213-9890 BSNClinicalTrials@bsci.com

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain; Boston Scientific Corporation

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04192591
• Other Study ID Numbers: A4082
• First Posted: December 10, 2019
• Last Update Posted: February 10, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Boston Scientific Corporation:

Lumbar Spinal Stenosis; LSS; Chronic Pain; Leg Pain

Additional relevant MeSH terms:

Spinal Stenosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases