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Spinal implant shows promise for easing leg pain in older adults

NCT ID NCT04192591

Symptom relief Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This study follows 166 people aged 45 and older who received the Superion IDS implant for lumbar spinal stenosis, a condition that narrows the spine and causes leg pain. The implant is designed to limit certain movements that worsen symptoms. Researchers are checking if patients have lasting symptom relief, fewer complications, and avoid additional surgeries over 5 years. The goal is to see how well the device works in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Superion IDS device (a minimally-invasive spinal implant)
What this could lead to
If successful, this study could confirm that the Superion IDS provides lasting symptom relief and reduces the need for more invasive surgery for lumbar spinal stenosis.
What could go wrong
This is an observational follow-up study, not a new treatment test. Results may not apply to all patients, and some may still need additional procedures or have complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

166 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Feb 2041

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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 Key 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

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Conditions

The condition(s) this trial relates to.

Chronic Pain lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbar spinal stenosis

Contacts and locations

Locations

  • Alliance Spine and Pain Centers

    Atlanta, Georgia, 30326, United States

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois, 60007, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Center for Interventional Pain and Spine

    Lancaster, Pennsylvania, 17601, United States

  • Centurion Spine and Pain

    Waycross, Georgia, 31501, United States

  • Coastal Research Institute, LLC

    Carlsbad, California, 92009, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • IPM Medical Group Inc.

    Walnut Creek, California, 94598, United States

  • MarinHealth Spine Institute

    Larkspur, California, 94939, United States

  • Michigan Pain Specialists

    Ypsilanti, Michigan, 48198, United States

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66215, United States

  • North Idaho Day Surgery

    Post Falls, Idaho, 83854, United States

  • Northwest Pain Care

    Spokane, Washington, 99201, United States

  • Pacific Sports and Spine, LLC

    Eugene, Oregon, 97401, United States

  • Precision Spine Care

    Tyler, Texas, 75701, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SC Pain and Spine Specialists

    Murrells Inlet, South Carolina, 29576, United States

  • Swedish Health Services

    Seattle, Washington, 98122, United States

  • The Orthopaedic Institute

    Gainesville, Florida, 32607, United States

  • The Spine and Nerve Center of Saint Francis Hospital

    Charleston, West Virginia, 25301, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • Vitamed Research

    Rancho Mirage, California, 92270, United States

  • Weill Cornell Medical University

    New York, New York, 10065, United States

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