Lumbar Spinal StenosisPRESSNCT04087811

Postmarket Registry for Evaluation of the Superion® Spacer

An observational study of Lumbar Spinal Stenosis, run by Boston Scientific Corporation at 66 sites in United States.

Completed

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

Trial summary

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS). 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® Indirect Decompression System (IDS)
Type of treatment: Medical device
How many people: 1,674 participants
Where: 66 sitesUnited States
Study dates: 28 Nov 2016to 1 Mar 2021
How long will I take part?: 1 Year
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis

Who may be able to join

male and female patients ≥45 years of age
symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)

Who cannot join

not contraindicated as described in the labeled indications for use

Trial locations and contacts

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

(ACT) Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
AMITA Health Bolingbrook Pain Management Center
Bolingbrook, Illinois, 60440
Center for Pain Control at Jasper Ambulatory Surgical Center
Brick, New Jersey, 08723
The Spine Center of Southeast Georgia
Brunswick, Georgia, 31525
NuVation Pain Group
Buena Park, California, 90621
Comprehensive Pain Physicians
Burbank, California, 91505
Pain and Wellness
Cambridge, Massachusetts, 01960
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, 25301
Rush University Medical Center Department of Anesthesiology
Chicago, Illinois, 60612
Cincinnati Comprehensive Pain Center
Cincinnati, Ohio, 45014
AXIS Spine Center
Coeur d'Alene, Idaho, 83815
Columbia Interventional Pain Center
Columbia, Missouri, 65203
North Lake Pain Consultants
Conroe, Texas, 77340
Dayton Outpatient Center
Dayton, Ohio, 45432
Performance Spine & Sports Physicians, PC
East Norriton, Pennsylvania, 19403
Upstate Orthopedics
East Syracuse, New York, 13057
Spine Institute of North America, LLC
East Windsor, New Jersey, 08520
Summit Medical Center
Edmond, Oklahoma, 73013
Center for Interventional Pain & Spine
Exton, Pennsylvania, 19341
Front Range Pain Medicine
Fort Collins, Colorado, 80525
Southeast Spine Associates
Fort Lauderdale, Florida, 33308
Holy Cross Interventional Spine and Pain Medicine
Fort Lauderdale, Florida, 33334
Pain Medicine Associates
Fountain Valley, California, 92708
Valley Pain Management
Fresno, California, 93720
Advanced Pain Management
Greenfield, Wisconsin, 53221
Comprehensive and Interventional Pain Management
Henderson, Nevada, 89052
Performance Pain and Sports Medicine
Houston, Texas, 77027
Jacksonville Spine Center
Jacksonville, Florida, 32256
Jupiter Interventional Pain Management
Jupiter, Florida, 33477
Kansas University Medical Center
Kansas City, Kansas, 66160
Fondren Orthopedic Group, LLC
Kingwood, Texas, 77339
Pain Consultants of San Diego
La Mesa, California, 91942
California Orthopedics & Spine
Larkspur, California, 94939
Pain Management Associates
Lee's Summit, Missouri, 64086
Remedy Pain Solutions, Inc.
Marina del Rey, California, 90292
Florida Pain Institute
Merritt Island, Florida, 32953
SC Pain and Spine
Murrells Inlet, South Carolina, 29576
Ainsworth Institute of Pain Management
New York, New York, 10022
Georgia Pain and Spine Care
Newnan, Georgia, 30265
Newport Beach Headache & Pain
Newport Beach, California, 92660
Lake Nona Medical Arts
Orlando, Florida, 32827
Neuroscience Research Center, LLC
Overland Park, Kansas, 66210
Pain Management Center of Paducah, KY
Paducah, Kentucky, 42003
HOPE Research Institute
Phoenix, Arizona, 85018
Southwest Florida Pain Center
Port Charlotte, Florida, 33948
Pain Consultants of San Diego- Poway
Poway, California, 92064
Advanced Pain Specialists
Reno, Nevada, 89511
Advanced Spine and Pain Center
San Antonio, Texas, 78240
Relieve Pain Center
San Diego, California, 92103
Paul Kim MD Pain Management
San Diego, California, 92108
San Diego Comprehensive Pain Management Center
San Diego, California, 92108
Source Healthcare
Santa Monica, California, 90403
Evolve Restorative Center
Santa Rosa, California, 95403
HOPE Research Institute
Scottsdale, Arizona, 85018
Florida Pain Management Associates
Sebastian, Florida, 32958
Premier Pain Center
Shrewsbury, New Jersey, 07702
University Clinical Research Center
Somerset, New Jersey, 08873
Southwest Spine and Pain
St. George, Utah, 84790
Tampa Pain Relief Center, Inc.
Tampa, Florida, 33613
Innovative Pain Treatment Solutions
Temecula, California, 92590
The Orthopaedic & Sports Medicine Center
Trumbull, Connecticut, 06611
Precision Spine Care
Tyler, Texas, 75701
Intergrated Pain Management Medical Group, Inc.
Walnut Creek, California, 94598
International Spine Pain & Performance Center
Washington D.C., District of Columbia, 20006
Pain Management at Garden State Medical Center
Whiting, New Jersey, 08759

Other trials in United States

About this study

Read the detailed description

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

Conditions: Lumbar Spinal Stenosis
Being tested: Superion® Indirect Decompression System (IDS)
Keywords: LSS
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® Indirect Decompression System (IDS)Device
Superion® Indirect Decompression System (IDS) (Superion® implant)

Study groups in NCT04087811
Study group	Role	What they receive
Superion® Indirect Decompression System (IDS)		Superion® Indirect Decompression System (IDS) - Interspinous Spacer Receives: Device: Superion® Indirect Decompression System (IDS)

What is being measured

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

Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated.
Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Measured: 3 Week Follow-Up Visit
Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated.
Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Measured: 6 Month Follow-Up Visit
Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated.
Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Measured: 12 Month Follow-Up Visit

Timeline

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

28 Nov 20161 Mar 2021

First posted12 Sep 2019
Study start28 Nov 2016
Primary completion1 Mar 2021
Study completion1 Mar 2021

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: Other
Time perspective: Prospective
Enrolment: 1,674 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT04087811
Sponsor's protocol ID: 16-VISS-01
Acronym: PRESS
Status last verified: Jun 2022
First submitted: 5 Jun 2019
Last updated: 6 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postmarket Registry for Evaluation of the Superion® Spacer
ClinicalTrials.gov ID: NCT04087811
Acronym / sponsor ID: PRESS / 16-VISS-01
Conditions: Lumbar Spinal Stenosis
Keywords: LSS
Study type: Observational
Recruitment status: Completed
Enrolment: 1,674 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 28 Nov 2016 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Mar 2021 (actual)
First posted: 12 Sep 2019 (actual)
Results: Posted 4 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
Superion® Indirect Decompression System (IDS)	–	Device: Superion® Indirect Decompression System (IDS)Superion® Indirect Decompression System (IDS) - Interspinous Spacer

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis

Key inclusion criteria (3 listed)

male and female patients ≥45 years of age
symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)

Key exclusion criteria (1 listed)

not contraindicated as described in the labeled indications for use

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® Indirect Decompression System (IDS)Superion® Indirect Decompression System (IDS) (Superion® implant)	Device	Superion® Indirect Decompression System (IDS)

Primary outcome

Vertiflex® Patient Satisfaction Survey
Time frame: 3 Week Follow-Up Visit
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Vertiflex® Patient Satisfaction Survey
Time frame: 6 Month Follow-Up Visit
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Vertiflex® Patient Satisfaction Survey
Time frame: 12 Month Follow-Up Visit
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.

Results and safety

Results posted to the registry on 4 Apr 2023, 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® Indirect Decompression System (IDS)	1,674	1,594

Primary outcome: Vertiflex® Patient Satisfaction Survey

Time frame: 3 Week Follow-Up Visit. Count of participants. Unit: Participants

Measure	Superion® Indirect Decompression System (IDS) n = 1311
Value	1147

Primary outcome: Vertiflex® Patient Satisfaction Survey

Time frame: 6 Month Follow-Up Visit. Count of participants. Unit: Participants

Measure	Superion® Indirect Decompression System (IDS) n = 980
Value	806

Primary outcome: Vertiflex® Patient Satisfaction Survey

Time frame: 12 Month Follow-Up Visit. Count of participants. Unit: Participants

Measure	Superion® Indirect Decompression System (IDS) n = 763
Value	630

Adverse events

Time frame: Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Superion® Indirect Decompression System (IDS)	5 of 1,674 (0.3%)	0 of 0	1 of 1,674

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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

66 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 66 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 3 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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 4 Apr 2023). 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?

Vertiflex® Patient Satisfaction Survey (time frame: 3 Week Follow-Up Visit). 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 NCT04087811.

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 6 Jul 2023.