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Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression

NCT00189605 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-08-26

No results posted yet for this study

Summary

The goal of this post-marketing surveillance study is to compare two procedures which are used to treat patients who require a disc decompression procedure. These procedures are: 1) plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy and rate of improvement in symptoms through the first six months following the procedure.

The principal objectives of this study are to determine whether subjects receiving the plasma disc decompression procedure demonstrate:

1. Improved clinical outcomes over subjects receiving TFESI
2. More rapid reversal of symptoms than subjects receiving TFESI

Conditions

  • Radicular Pain

Interventions

DEVICE

Perc-DLR/Perc-DLG

Device technique will be used per IFU

DRUG

Fluoroscopy guided transforaminal epidural steroid injection (TFESI)

Injection of steroid solution into the lumbar level

Sponsors & Collaborators

  • ArthroCare Corporation

    lead OTHER

Principal Investigators

  • Peter Gerzten, MD · Univ. of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-12-31
Completion
2009-04-30

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 NCT00189605 on ClinicalTrials.gov