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U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
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
Who can join
Ages 22 and older · All sexes
Full eligibility criteria
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, * Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated * Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response, * Pregnant or breast-feeding women, * Patients subject to a legal protection measure, * Patients already participating in another conflicting interventional clinical study, * Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference. * Patients having a coagulation abnormalities or bleeding disorder * Patients having an active infection on the day of intervention * Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach * Exclusion criteria linked to the freehand procedure have been discussed and validated
About the study
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.
What is being tested
- Percutaneous procedure in the MSK structures of the pelvis and/or the spine (device)
Sponsor: Precision IO Group · Participants: 60 · Started: Apr 28, 2026
Contact the study team
- Erin Meyers · Phone: 305 731-2901
- Marion Chassouant · Phone: 448 19 40 50
Official record on ClinicalTrials.gov — NCT07325578
Locations in the U.S.
| California | UC San Diego, San Diego |
| Florida | Baptist Hospital Of Miami, Inc, Miami |
| Illinois | Rush University Medical Center, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.