NCT07325578 U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
| NCT ID | NCT07325578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Precision IO Group |
| Condition | Bone Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sean Tutton, MD
PRINCIPAL INVESTIGATOR
UC San Diego
Frequently Asked Questions
Who can join the NCT07325578 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Bone Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07325578 currently recruiting?
Yes, NCT07325578 is actively recruiting participants. Contact the research team at clinical.department@quantumsurgical.com for enrollment information.
Where is the NCT07325578 trial being conducted?
This trial is being conducted at San Diego, United States, Miami, United States, Chicago, United States.
Who is sponsoring the NCT07325578 clinical trial?
NCT07325578 is sponsored by Precision IO Group. The principal investigator is Sean Tutton, MD at UC San Diego. The trial plans to enroll 60 participants.