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U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Sponsor: Quantum Surgical
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.
Official title: 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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03
Completion Date
2026-09
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Percutaneous procedure in the MSK structures of the pelvis and/or the spine
The introducer placement is performed with the Epione device.
Locations (3)
UC San Diego
San Diego, California, United States
Baptist Hospital Of Miami, Inc
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States