iO-Flex® System Decompression for Spondylolisthesis
(STRiDE Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen bySylvain Palmer, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baxano Surgical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.

Research Team

Sylvain Palmer, M.D.

Principal Investigator

Neurological Surgery Medical Associates

Eligibility Criteria

This trial is for adults over 18 with leg or buttock pain due to spinal stenosis and a confirmed grade I degenerative lumbar spondylolisthesis. Participants must have tried non-surgical treatments for at least 6 months without success, have an ODI score of at least 30/100, and an NRS leg pain score of at least 4/10. They should be able to consent and complete questionnaires.

Inclusion Criteria

My back pain affects my daily life significantly.

I am over 18 years old.

I have pain in my leg or buttock, with or without back pain.

See 6 more

Exclusion Criteria

Current involvement in another drug or device clinical trial

I have cauda equina syndrome.

I have a bone condition like Paget's disease affecting my spine.

See 24 more

Treatment Details

Interventions

Decompression using the iO-Flex® system (Other)

Trial OverviewThe study tests the iO-Flex® System's effectiveness in decompressing the spine for patients with spinal stenosis and stable grade I spondylolisthesis. It assumes a positive response rate of 55% based on precision estimates.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SurgeryExperimental Treatment1 Intervention

Decompression using the iO-Flex® system