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A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE) | Clinical Trials | Clareo Health

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A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

NCT04192591•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (23)

Coastal Research Institute, LLC

Carlsbad, California, United States

MarinHealth Spine Institute

Larkspur, California, United States

Vitamed Research

Rancho Mirage, California, United States

IPM Medical Group Inc.

Walnut Creek, California, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

The Orthopaedic Institute

Gainesville, Florida, United States

Alliance Spine and Pain Centers

Atlanta, Georgia, United States

Centurion Spine and Pain

Waycross, Georgia, United States

North Idaho Day Surgery

Post Falls, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

January 30, 2020

Primary Completion Date

February 1, 2038

Completion Date

February 1, 2041

Last Updated

March 4, 2026

Enrollment

166

ACTUAL participants

Conditions

Lumbar Spinal Stenosis

Interventions

Superion™ IDS device

DEVICE

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

NCT04992572

Lumbar Spinal Stenosis

View study

RECRUITINGPHASE4

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Inclusion Criteria

Exclusion Criteria

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Home-based Cycling for People With Lumbar Spinal Stenosis

Prediction of TEI Success in Sciatica

Balance Amongst Patients With Lumbar Spinal Stenosis

Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot