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
Precision IO Group
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients ≥22 years old, * Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia, * Patients who have signed an IRB-approved informed consent form * Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure * Inclusion criteria linked to the freehand procedure have been discussed and validated Exclusion Criteria: * Patients with contraindication to undergo general anesthesia, * Patients unable to maintain appropriate breathing control, * Pati…
Interventions
- DevicePercutaneous 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 DiegoSan Diego, California
- Baptist Hospital Of Miami, IncMiami, Florida
- Rush University Medical CenterChicago, Illinois