NCT07325578

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Quantum Surgical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Tumor
• Osteoporosis
• Traumatic Fracture

Interventions

Type	Name	Description
DEVICE	Percutaneous procedure in the MSK structures of the pelvis and/or the spine	The introducer placement is performed with the Epione device.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-01-08
• Last updated: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study