DDD Clinical Trial
— OptiLIF™Official title:
An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
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.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 |
Observational Model: Case-Only
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles Brain and Spine Institute | Los Angeles | California |
United States | Flagler Hospital | St. Augustine | Florida |
Lead Sponsor | Collaborator |
---|---|
Interventional Spine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fusion | Image Assessment | 1 year | No |
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