The PerX360º System™ Registry

Status unconfirmed

Conditions studied: DDD

In brief

This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

Key facts

Study ID

NCT01796535

Run by

Interventional Spine, Inc.

People needed

125

Starts

2012-11-01

Expected to finish

2013-06-01

Last updated by the study team

2013-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient understands the nature of the procedure and provides written informed consent
• Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
• Age > 18 years
• Patient is treated with the Optiport™ and Opticage™ products
• Exclusion Criteria:None

Where it is running

• Los Angeles Brain and Spine Institute — Los Angeles, California, United States (enrolling)
• Flagler Hospital — Saint Augustine, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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