A 5-year Superion® IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04192591 |
Recruitment Status :
Recruiting
First Posted : December 10, 2019
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lumbar Spinal Stenosis | Device: Superion® IDS device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 30, 2020 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | January 2027 |

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. |
- 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:
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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)
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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
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- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192591
Contact: Natalie Bloom Lyons | 7632289040 ext 7632289040 | lyonsn@bsci.com | |
Contact: Diane Keesey | 661-949-4175 | diane.keesey@bsci.com |
United States, California | |
Vitamed Research | Recruiting |
Rancho Mirage, California, United States, 92270 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Florida | |
Holy Cross Hospital | Recruiting |
Fort Lauderdale, Florida, United States, 33308 | |
Contact: Boston Scientific Clinical Research Manager | |
Contact 855-213-9890 BSNClinicalTrials@bsci.com | |
The Orthopaedic Institute | Recruiting |
Gainesville, Florida, United States, 32607 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Georgia | |
Centurion Spine and Pain | Recruiting |
Waycross, Georgia, United States, 31501 | |
Contact: Boston Scientific Clinical Research 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Idaho | |
Axis Spine Center | Recruiting |
Coeur d'Alene, Idaho, United States, 83815 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Michigan | |
Forest Health Medical Center | Recruiting |
Ypsilanti, Michigan, United States, 48198 | |
Contact: Boston Scientific Clinical Research Manager | |
Contact 8552139890 BSNClinicalTrials@bsci.com | |
United States, Oregon | |
Pacific Sports and Spine, LLC | Recruiting |
Eugene, Oregon, United States, 97401 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Pennsylvania | |
Center for Interventional Pain and Spine | Recruiting |
Lancaster, Pennsylvania, United States, 17601 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, South Carolina | |
SC Pain and Spine Specialists | Recruiting |
Murrells Inlet, South Carolina, United States, 29576 | |
Contact: Boston Scientific Clinical Research Manager | |
Contact 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Texas | |
Central Texas Pain Institute | Recruiting |
Killeen, Texas, United States, 76542 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
Precision Spine Care | Recruiting |
Tyler, Texas, United States, 75701 | |
Contact: Boston Scientific Clinical Research Manager | |
Contact 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, Washington | |
Northwest Pain Care | Recruiting |
Spokane, Washington, United States, 99201 | |
Contact: Boston Scientific Clinical Research Manager 855-213-9890 BSNClinicalTrials@bsci.com | |
United States, West Virginia | |
The Spine and Nerve Center of Saint Francis Hospital | Recruiting |
Charleston, West Virginia, United States, 25301 | |
Contact: Boston Scientific Clinical Research Manager | |
Contact 855-213-9890 BSNClinicalTrials@bsci.com |
Study Director: | Roshini Jain | Boston Scientific Corporation |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT04192591 |
Other Study ID Numbers: |
A4082 |
First Posted: | December 10, 2019 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
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 |
Lumbar Spinal Stenosis LSS Chronic Pain Leg Pain |
Spinal Stenosis Spinal Diseases Bone Diseases Musculoskeletal Diseases |