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Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

NCT00693784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-06-22

Study results available
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Summary

The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy information.

Conditions

  • Low Back Pain

Interventions

BIOLOGICAL

Biostat® Disc Augmentation System

Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device

Sponsors & Collaborators

  • Spinal Restoration, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin J Pauza, MD · Spine Specialists, PA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-02-28
Completion
2011-01-31

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 NCT00693784 on ClinicalTrials.gov