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Interspinous Spacer

Investigating Superion™ In Spinal Stenosis

N/A
Waitlist Available
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 months
Awards & highlights
No Placebo-Only Group

Summary

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Eligible Conditions
  • Intermittent Claudication
  • Lumbar Spinal Stenosis

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Subjects With Clinically Significant Improvement in Outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Interspinous Process Spacer Device
Group II: 2Active Control1 Intervention
Interspinous Process Spacer Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Superion™ Interspinous Spacer
2008
N/A
~400

Find a Location

Who is running the clinical trial?

VertiFlex, IncorporatedIndustry Sponsor
2 Previous Clinical Trials
180 Total Patients Enrolled
Boston Scientific CorporationLead Sponsor
745 Previous Clinical Trials
857,451 Total Patients Enrolled
2 Trials studying Intermittent Claudication
2,150 Patients Enrolled for Intermittent Claudication
Roshini JainStudy DirectorBoston Scientific Corporation
30 Previous Clinical Trials
25,904 Total Patients Enrolled
~22 spots leftby Dec 2025
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