Lumbar Spinal StenosisNCT04192591
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
A study testing Superion™ IDS device in people with Lumbar Spinal Stenosis, run by Boston Scientific Corporation at 23 sites in United States.
Trial summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Superion™ IDS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 23 sitesUnited States
- Study dates
- 30 Jan 2020to Feb 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Alliance Spine and Pain Centers
Atlanta, Georgia, 30326
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Coastal Research Institute, LLC
Carlsbad, California, 92009
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, 25301
Rush University Medical Center
Chicago, Illinois, 60612
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
The Orthopaedic Institute
Gainesville, Florida, 32607
University of Kansas Hospital
Kansas City, Kansas, 66160
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
MarinHealth Spine Institute
Larkspur, California, 94939
SC Pain and Spine Specialists
Murrells Inlet, South Carolina, 29576
Weill Cornell Medical University
New York, New York, 10065
Neuroscience Research Center, LLC
Overland Park, Kansas, 66215
North Idaho Day Surgery
Post Falls, Idaho, 83854
Vitamed Research
Rancho Mirage, California, 92270
Swedish Health Services
Seattle, Washington, 98122
Northwest Pain Care
Spokane, Washington, 99201
Precision Spine Care
Tyler, Texas, 75701
IPM Medical Group Inc.
Walnut Creek, California, 94598
Centurion Spine and Pain
Waycross, Georgia, 31501
Michigan Pain Specialists
Ypsilanti, Michigan, 48198
About this study
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Read the detailed description
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Superion™ IDS device
- Keywords
- Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain
- Medical subject headings
- Spinal Stenosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superion™ IDS deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Superion™ IDS device | Experimental | Superion™ Indirect Decompression System (IDS) Receives: Device: Superion™ IDS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-Months
Secondary outcomes (1)
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale
Measured: 24-, 36-, 48- and 60-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start30 Jan 2020
- Primary completionFeb 2038 (estimated)
- Study completionFeb 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192591
- Sponsor's protocol ID
- A4082
- Status last verified
- Oct 2026
- First submitted
- 6 Dec 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
- ClinicalTrials.gov ID
- NCT04192591
- Acronym / sponsor ID
- A4082
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- Feb 2038 (estimated)
- Study completion
- Feb 2041 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Superion™ IDS device | Experimental | Device: Superion™ IDS deviceSuperion™ Indirect Decompression System (IDS) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superion™ IDS deviceThe 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. | Device | Superion™ IDS device |
Primary outcome
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
1 secondary outcome
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
Time frame: 24-, 36-, 48- and 60-Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Bloom Lyons study director
Boston Scientific Corporation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superion™ IDS device in people with Lumbar Spinal Stenosis, run by Boston Scientific Corporation at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success at the 24-month follow-up visit (time frame: 24-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.