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NCT00205855 · ClinicalTrials.gov registry record · Phase 3

An Implantable Spinal Cord Stimulation Pain Management System

A Phase 3 study of Pain and Chronic Pain, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
65
Enrollment target
9
Study locations

NCT00205855 is a Phase 3 study of Pain and Chronic Pain that has completed, run by Boston Scientific Corporation. The registered enrollment target is 65 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 6 states.

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The verdict

NCT00205855, a Phase 3 study of Pain and Chronic Pain, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
65 participants
Enrollment target
9
Study locations

Study Summary

There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

Interventions

  • DEVICE Precision SCS

Study Locations (9)

Texas

  • Dallas Neurological Associates - Dallas
  • River Oaks Pain Management - Houston
  • Texas Back Institute - Plano

California

  • California Pain Medicine Centers - Los Angeles
  • Pacific Pain Treatment Center - San Francisco

Alabama

  • Alabama Pain Center - Huntsville

Montana

  • Yellowstone Neurological Associates - Billings

New York

  • Northshore University Hospital - Syosset

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2003-02
Est. Completion 2005-03
Phase Phase 3

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT00205855

The ClinicalTrials.gov registry entry for NCT00205855 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (79% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Precision SCS is the first listed.

NCT00205855 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00205855 about?

NCT00205855 is a clinical study titled "An Implantable Spinal Cord Stimulation Pain Management System". There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay...

What is the current status of trial NCT00205855?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2003-02. Estimated completion is 2005-03.

What conditions does trial NCT00205855 study?

This clinical trial studies the following conditions: Pain, Chronic Pain, Back Pain, Pain, Intractable, Failed Back Surgery Syndrome.

What interventions are being tested in trial NCT00205855?

The interventions under investigation include: Precision SCS (DEVICE).

Who is sponsoring clinical trial NCT00205855?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00205855 being conducted?

This trial has 9 study locations across Alabama, California, Montana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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