Lumbar Spinal StenosisPRESS2NCT04563793

Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

An observational study of Lumbar Spinal Stenosis, run by Boston Scientific Corporation at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 21 years and older
Conditions the study is for: Lumbar Spinal Stenosis
What is being tested?: Superion™ IDS
Type of treatment: Medical device
How many people: 129 participants
Where: 23 sitesUnited States
Study dates: 8 Oct 2020to 20 Mar 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects with moderate Lumbar Spinal Stenosis

Who may be able to join

Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
Signed a valid, IRB approved informed consent form

Who cannot join

Meets any contraindication in BSC Indirect Decompression Systems local IFU

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Center for Interventional Pain and Spine
Bryn Mawr, Pennsylvania, 19010
Rush University Medical Center
Chicago, Illinois, 60612
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308
Pain Medicine Associates
Fountain Valley, California, 92708
Comprehensive and Interventional Pain Management LLP
Henderson, Nevada, 89052
Louis J. Raso, MD, PA
Jupiter, Florida, 33477
University of Kansas Hospital
Kansas City, Kansas, 66160
Advanced Spine Pain Solution
Laredo, Texas, 78041
California Orthopedics & Spine
Larkspur, California, 94939
KC Pain Centers
Lee's Summit, Missouri, 64086
Florida Pain Institute
Merritt Island, Florida, 32953
Georgia Pain and Spine Care, Inc.
Newnan, Georgia, 30265
Southwest Florida Pain Center
Port Charlotte, Florida, 33948
North Idaho Day Surgery LLC
Post Falls, Idaho, 83854
Relieve Pain Center, Inc.
San Diego, California, 92103
Source Healthcare
Santa Monica, California, 90403
Pacific Research Institute
Santa Rosa, California, 95403
Premier Pain Center
Shrewsbury, New Jersey, 07702
University Clinical Research Center
Somerset, New Jersey, 08873
The Toledo Clinic
Toledo, Ohio, 43623
Precision Spine Care
Tyler, Texas, 75701
IPM Medical Group Inc
Walnut Creek, California, 94598
Centurion Spine and Pain Centers
Waycross, Georgia, 31501

Other trials in United States

About this study

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

Read the detailed description

The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Conditions: Lumbar Spinal Stenosis
Being tested: Superion™ IDS
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Superion™ IDSDevice
All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.

Study groups in NCT04563793
Study group	Role	What they receive
Superion™ IDS		All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. Receives: Device: Superion™ IDS

What is being measured

The primary outcome is the main question the study is designed to answer.

Low Back Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Measured: Up to 3 years post-procedure
Left Leg Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Measured: Up to 3 years post-procedure
Right Leg Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Measured: Up to 3 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202020 Mar 2023

First posted24 Sep 2020
Study start8 Oct 2020
Primary completion20 Mar 2023
Study completion20 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04563793
Sponsor's protocol ID: A4086
Acronym: PRESS2
Status last verified: Sep 2024
First submitted: 17 Sep 2020
Last updated: 13 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis

All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
ClinicalTrials.gov ID: NCT04563793
Acronym / sponsor ID: PRESS2 / A4086
Conditions: Lumbar Spinal Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 8 Oct 2020 (actual)
Primary completion: 20 Mar 2023 (actual)
Study completion: 20 Mar 2023 (actual)
First posted: 24 Sep 2020 (actual)
Results: Posted 13 Jan 2025

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Superion™ IDS	–	Device: Superion™ IDSAll patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with moderate Lumbar Spinal Stenosis

Key inclusion criteria (2 listed)

Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
Signed a valid, IRB approved informed consent form

Key exclusion criteria (1 listed)

Meets any contraindication in BSC Indirect Decompression Systems local IFU

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™ IDSAll patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.	Device	Superion™ IDS

Primary outcome

Low Back Pain Responder Rate
Time frame: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Left Leg Pain Responder Rate
Time frame: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Right Leg Pain Responder Rate
Time frame: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)

Results and safety

Results posted to the registry on 13 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Superion™ IDS	129	23

Primary outcome: Low Back Pain Responder Rate

Time frame: Up to 3 years post-procedure. Count of participants. Unit: Participants

Measure	Superion™ IDS 6-Month Follow-up n = 30	Superion™ IDS 1-Year Follow-up n = 11	Superion™ IDS 2-Year Follow-up n = 8	Superion™ IDS 3-Year Follow-up n = 7
Value	17	3	1	2

Population analysed: Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.

Primary outcome: Left Leg Pain Responder Rate

Time frame: Up to 3 years post-procedure. Count of participants. Unit: Participants

Measure	Superion™ IDS 6-Month Follow-up n = 23	Superion™ IDS 1-Year Follow-up n = 9	Superion™ IDS 2-Year Follow-up n = 4	Superion™ IDS 3-Year Follow-up n = 5
Value	15	7	2	0

Primary outcome: Right Leg Pain Responder Rate

Time frame: Up to 3 years post-procedure. Count of participants. Unit: Participants

Measure	Superion™ IDS 6-Month Follow-up n = 25	Superion™ IDS 1-Year Follow-up n = 10	Superion™ IDS 2-Year Follow-up n = 7	Superion™ IDS 3-Year Follow-up n = 6
Value	18	6	3	0

Adverse events

Time frame: From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Superion™ IDS	12 of 129 (9.3%)	3 of 129 (2.3%)	0 of 129

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Spinal Stenosis

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis

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?

An observational study of 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Low Back Pain Responder Rate (time frame: Up to 3 years post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04563793.

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 13 Jan 2025.