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Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study

Spinal Stenosis Clinical Trial

Official title:
Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001

Clinical Trial Summary

The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. No additional patient treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01485289
Study type Observational
Source Rachiotek LLC
Contact
Status Completed
Phase N/A
Start date August 2011
Completion date December 2012
View Details
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