- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563793
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer (PRESS2)
June 6, 2023 updated by: Boston Scientific Corporation
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ann Yamano
- Phone Number: 855-213-9890
- Email: BSNClinicalTrials@bsci.com
Study Locations
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California
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Fountain Valley, California, United States, 92708
- Pain Medicine Associates
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Larkspur, California, United States, 94939
- California Orthopedics & Spine
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San Diego, California, United States, 92103
- Relieve Pain Center, Inc.
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Santa Monica, California, United States, 90403
- Source Healthcare
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Santa Rosa, California, United States, 95403
- Pacific Research Institute
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Walnut Creek, California, United States, 94598
- IPM Medical Group Inc
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital Inc.
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Jupiter, Florida, United States, 33477
- Louis J. Raso, MD, PA
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Merritt Island, Florida, United States, 32953
- Florida Pain Institute
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Port Charlotte, Florida, United States, 33948
- Southwest Florida Pain Center
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Georgia
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Newnan, Georgia, United States, 30265
- Georgia Pain and Spine Care, Inc.
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Waycross, Georgia, United States, 31501
- Centurion Spine and Pain Centers
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Idaho
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Post Falls, Idaho, United States, 83854
- North Idaho Day Surgery LLC
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Hospital
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Missouri
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Lee's Summit, Missouri, United States, 64086
- KC Pain Centers
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Nevada
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Henderson, Nevada, United States, 89052
- Comprehensive and Interventional Pain Management Llp
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New Jersey
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Shrewsbury, New Jersey, United States, 07702
- Premier Pain Center
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Somerset, New Jersey, United States, 08873
- University Clinical Research Center
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Ohio
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Toledo, Ohio, United States, 43623
- The Toledo Clinic
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Center for Interventional Pain and Spine
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Texas
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Laredo, Texas, United States, 78041
- Advanced Spine Pain Solution
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Tyler, Texas, United States, 75701
- Precision Spine Care
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects with moderate Lumbar Spinal Stenosis
Description
Key Inclusion Criteria:
- 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:
- Meets any contraindication in BSC Indirect Decompression Systems local IFU
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Superion™ IDS
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.
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All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low Back Pain Responder rate
Time Frame: Up to 3 years post-procedure
|
Proportion of subjects with an improvement of 20 mm for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
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Up to 3 years post-procedure
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Leg Pain Responder rate
Time Frame: Up to 3 years post-procedure
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Proportion of subjects with an improvement of 20 mm for leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
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Up to 3 years post-procedure
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Pain Relief
Time Frame: Up to 3 years post-procedure
|
Percent Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR)
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Up to 3 years post-procedure
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Quality of Life (QoL)
Time Frame: Up to 3 years post-procedure
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Change in overall quality of life at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (EQ-5D-5L)
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Up to 3 years post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Natalie Bloom Lyons, Boston Scientific Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2020
Primary Completion (Actual)
March 20, 2023
Study Completion (Actual)
March 20, 2023
Study Registration Dates
First Submitted
September 17, 2020
First Submitted That Met QC Criteria
September 23, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4086
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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