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Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

NCT02414698 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-03-02

Study results available
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Summary

To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation with symptoms that persist following a treatment course of conservative management including physical therapy and anti-inflammatory medication.

Conditions

  • Lumbar Herniated Disc

Interventions

PROCEDURE

Percutaneous Hydrodiscectomy

The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.

DRUG

TESI

Transforaminal epidural steroid injections given in the lumbar spine.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Sayed E Wahezi, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT02414698 on ClinicalTrials.gov