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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04192591
• Collaborator: (none)
• Enrollment: 214
• Locations: 25
• Arm: 1
• Anticipated Duration (Months): 147
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.1

Study Details

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	N/A

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
• Anticipated Enrollment: 214 participants
• Allocation: N/A
• 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: Jan 30, 2020
• Anticipated Primary Completion Date: Jun 1, 2029
• Anticipated Study Completion Date: May 1, 2032

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 [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: 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

1. Patient Satisfaction: VertiFlex® Patient Satisfaction Survey [24-, 36-, 48- and 60-Months]

   Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Coastal Pain and Spinal Diagnostics	Carlsbad	California	United States	92009
2	Vitamed Research	Rancho Mirage	California	United States	92270
3	Pacific Research Institute	Santa Rosa	California	United States	95403
4	IPM Medical Group Inc.	Walnut Creek	California	United States	94598
5	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
6	The Orthopaedic Institute	Gainesville	Florida	United States	32607
7	Florida Pain Management	Sebastian	Florida	United States	32958
8	Alliance Spine and Pain Centers	Atlanta	Georgia	United States	30326
9	Centurion Spine and Pain	Waycross	Georgia	United States	31501
10	Axis Spine Center	Coeur d'Alene	Idaho	United States	83815
11	Rush University Medical Center	Chicago	Illinois	United States	60612
12	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
13	University of Kansas Hospital	Kansas City	Kansas	United States	66160
14	Neuroscience Research Center, LLC	Overland Park	Kansas	United States	66215
15	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
16	Forest Health Medical Center	Ypsilanti	Michigan	United States	48198
17	Weill Cornell Medical University	New York	New York	United States	10065
18	Pacific Sports and Spine, LLC	Eugene	Oregon	United States	97401
19	Center for Interventional Pain and Spine	Lancaster	Pennsylvania	United States	17601
20	SC Pain and Spine Specialists	Murrells Inlet	South Carolina	United States	29576
21	Central Texas Pain Institute	Killeen	Texas	United States	76542
22	Precision Spine Care	Tyler	Texas	United States	75701
23	Swedish Health Services	Seattle	Washington	United States	98122
24	Northwest Pain Care	Spokane	Washington	United States	99201
25	The Spine and Nerve Center of Saint Francis Hospital	Charleston	West Virginia	United States	25301

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The SCOPE Study for Spinal Stenosis (vertiflexstudy.com)

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04192591
• Other Study ID Numbers: A4082
• First Posted: Dec 10, 2019
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Aug 3, 2022