The PerX360º System™ Registry
OptiLIF™
An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
1 other identifier
observational
125
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 15, 2013
March 1, 2013
7 months
December 10, 2012
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Fusion
Image Assessment
1 year
Study Arms (1)
PerX360º System™
Patients treated with PerX360º System™
Eligibility Criteria
Adult subjects treated with the Optiport™ and Opticage™ products
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Los Angeles Brain and Spine Institute
Los Angeles, California, 90036, United States
Flagler Hospital
Saint Augustine, Florida, 32086, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2012
First Posted
February 21, 2013
Study Start
November 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 15, 2013
Record last verified: 2013-03