Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy
Summary
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.
Arms & interventions
- DevicePercutaneous procedure in the MSK structures of the pelvis and/or the spine
The introducer placement is performed with the Epione device.
Outcome measures
Primary
Feasability
Rate of successful insertions of the introducer with the assistance of the Epione device.
Time frame: 5 months
Secondary
Safety Adverse Event
Time frame: 6 months
Accuracy
Time frame: 5 months
Eligibility criteria
Study locations (3)
UC San Diego
San Diego, California, 92093
Baptist Hospital Of Miami, Inc
Miami, Florida, 33176
Rush University Medical Center
Chicago, Illinois, 60612