Tests a robotic device to guide needle placement in pelvis and spine procedures
Tests the Epione robotic system to guide needle placement in adults with bone conditions.
Plain-language title generated from the registry record
Registry title: U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Key facts
- Where
- Chicago, Miami, and San Diego, United StatesSee the 3 sites
Where in United States
- Rush University Medical CenterChicago, United StatesTaking people
- Baptist Hospital Of Miami, IncMiami, United StatesTaking people
- UC San DiegoSan Diego, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Precision IO Group
- Trial code
- NCT07325578
- Record updated
- 20 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach; Patients having a coagulation abnormalities or bleeding disorder; Patients having an active infection on the day of intervention; 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; Exclusion criteria linked to the freehand procedure have been discussed and validated.