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The MiDAS ENCORE Study

NCT02093520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-12-06

Study results available
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Summary

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Conditions

  • Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Interventions

PROCEDURE

MILD Procedure

The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.

DRUG

Epidural Steroid Injection

Injection of epidural steroids into the lumbar spine

Sponsors & Collaborators

  • Vertos Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ramsin Benyamin, MD · AAPM; ASIPP; ISIS; ASA

  • Peter Staats, MD · AAPM; ASIPP; ASA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093520 on ClinicalTrials.gov