NCT01485289

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Rachiotek LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Stenosis

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-12-05
• Last updated: 2016-10-04

Locations

1 site across 1 country: United States