Clinical Trial

U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures

Study acronym: EPIOS
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
notable Primary completion pushed: 2026-09 -> 2027-01 2026-07-21
minor Completion pushed: 2026-10 -> 2027-03 2026-07-21
critical Recruitment opened 2026-05-06
notable Sponsor changed: Quantum Surgical -> Precision IO Group 2026-04-21
notable Primary completion pushed: 2026-08 -> 2026-09 2026-04-21
minor Completion pushed: 2026-09 -> 2026-10 2026-04-21
Trial Details
NCT Number NCT07325578
Lead Sponsor Precision IO Group
Collaborators: ICUREsearch, Endpoint, LLC
Conditions Bone Tumor, Osteoporosis, Traumatic Fracture
Enrollment 60 participants
Start Date 2026-04-28
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-20