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NCT00189605 · ClinicalTrials.gov registry record · Phase 4
Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression
A Phase 4 study, sponsored by ArthroCare Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
NCT00189605 is a Phase 4 study that has completed, run by ArthroCare Corporation. The registered enrollment target is 90 participants.
The verdict
NCT00189605, a Phase 4 study, has completed, sponsored by ArthroCare Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
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
Interventions
- DEVICE Perc-DLR/Perc-DLG
- DRUG Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00189605
The ClinicalTrials.gov registry entry for NCT00189605 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ArthroCare Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Perc-DLR/Perc-DLG is the first listed.
NCT00189605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00189605 about?
NCT00189605 is a clinical study titled "Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression". 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 stero...
What is the current status of trial NCT00189605?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2004-09. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00189605?
The interventions under investigation include: Perc-DLR/Perc-DLG (DEVICE), Fluoroscopy guided transforaminal epidural steroid injection (TFESI) (DRUG).
Who is sponsoring clinical trial NCT00189605?
This trial is sponsored by ArthroCare Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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