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Spinal Implant

Superion™ IDS Device for Spinal Stenosis

N/A
Recruiting
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-, 36-, 48- and 60-months
Awards & highlights

Study Summary

This trial is looking at how well the Superion IDS works in real-world settings.

Who is the study for?
This trial is for individuals over 45 with lumbar spinal stenosis, experiencing leg/buttock/groin pain that improves when bending forward. Participants must understand the study and commit to follow-ups. Exclusions include those with fixed motor deficits, conditions that could affect outcome reporting, involvement in conflicting trials, or only axial back pain.Check my eligibility
What is being tested?
The Superion™ IDS device is being tested to gather real-world data on its effectiveness in routine clinical practice for patients suffering from lumbar spinal stenosis.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential nerve damage, infection risk post-surgery and possible failure of the device to relieve symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 45 years old or older.
Select...
I have ongoing leg, buttock, or groin pain that gets better when I sit or bend.
Select...
I have been diagnosed with narrowing of the spinal canal in my lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-, 36-, 48- and 60-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-, 36-, 48- and 60-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of success at the 24-month follow-up visit
Secondary outcome measures
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey

Trial Design

1Treatment groups
Experimental Treatment
Group I: Superion™ IDS deviceExperimental Treatment1 Intervention
Superion™ Indirect Decompression System (IDS)

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
932,856 Total Patients Enrolled
Natalie Bloom LyonsStudy DirectorBoston Scientific Corporation
15 Previous Clinical Trials
24,554 Total Patients Enrolled
Roshini JainStudy DirectorBoston Scientific Corporation
30 Previous Clinical Trials
26,081 Total Patients Enrolled

Media Library

Superion® IDS device (Spinal Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04192591 — N/A
Lumbar Spinal Stenosis Research Study Groups: Superion™ IDS device
Lumbar Spinal Stenosis Clinical Trial 2023: Superion® IDS device Highlights & Side Effects. Trial Name: NCT04192591 — N/A
Superion® IDS device (Spinal Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04192591 — N/A
Lumbar Spinal Stenosis Patient Testimony for trial: Trial Name: NCT04192591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities to join this experiment?

"According to clinicaltrials.gov, this study is currently recruiting participants and was first posted in January 2020 before being updated on November 7th 2022."

Answered by AI

What is the aggregate amount of participants joining this experiment?

"For the success of this experiment, 214 eligible participants are required. Boston Scientific Corporation will be running it from multiple sites including Coastal Pain and Spinal Diagnostics in Carlsbad, Florida and Holy Cross Hospital in Fort Lauderdale, Georgia."

Answered by AI

In which geographical areas is this medical investigation being conducted?

"This research trial is currently enrolling participants at 25 distinct locations. These sites are spread across the United States, with 3 notable clinics located in Carlsbad, Fort Lauderdale and Santa Rosa. To reduce potential travel demands, it would be prudent to select a clinic closest to your residence if you choose to participate."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Holy Cross Hospital
Pacific Sports and Spine, LLC
Precision Spine Care
Other
How many prior treatments have patients received?
3+
0
2

Why did patients apply to this trial?

Disc problems ongoing for many years. I've tried other methods and nothing seems to help.
PatientReceived no prior treatments
The pain in my lumbar region was getting worse, when my grandson found this trial and informed me of it.
PatientReceived no prior treatments
Chronic back, leg and groin pain for decades that hasn’t responded well to medications, PT, chiropractic, steroidal epidural injections or RF ablation.
PatientReceived 2+ prior treatments
I have had DDD and DSS for over 10 years. I am currently seeing pain management, but my pain is not controlled via pain medication and I found no relief from PT either. I am hoping this might be an option.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Precision Spine Care: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
2020. "A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04192591.
~117 spots leftby Jun 2029
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