NCT07325578Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 28 Apr 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Precision IO Group
- Diseases
- Osteoporosis
- NCT number
- NCT07325578
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Apr 2026 to the primary completion date, Jan 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach
Other illness
- Patients having a coagulation abnormalities or bleeding disorder
- Patients having an active infection on the day of intervention
Other
- 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
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Baptist Hospital Of Miami, Inc Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| UC San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.