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

NCT ID: NCT07325578

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-09-30

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.

Conditions

Bone Tumor; Osteoporosis; Traumatic Fracture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CT guidance

The procedure is performed under CT guidance.

Group Type: EXPERIMENTAL

Percutaneous procedure in the MSK structures of the pelvis and/or the spine

Intervention Type: DEVICE

The introducer placement is performed with the Epione device.

CBCT guidance

The procedure is performed under CBCT guidance.

Group Type: EXPERIMENTAL

Percutaneous procedure in the MSK structures of the pelvis and/or the spine

Intervention Type: DEVICE

The introducer placement is performed with the Epione device.

Interventions

Percutaneous procedure in the MSK structures of the pelvis and/or the spine

The introducer placement is performed with the Epione device.

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quantum Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Tutton, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

UC San Diego

San Diego, California, United States

Baptist Hospital Of Miami, Inc

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Central Contacts

Laetitia Messner

Role: CONTACT

clinical.department@quantumsurgical.com

305 731-2901 ext. +1

Marion Chassouant

Role: CONTACT

clinical.department@quantumsurgical.com

448 19 40 50 ext. +33

Facility Contacts

Sean Tutton, MD

Role: primary

stutton@health.ucsd.edu

858-249-0460 ext. +1

Gina Landinez, MD

Role: primary

Gina.Landinez@baptisthealth.net

786-596-2373 ext. +1

Jordan Tasse, MD

Role: primary

Jordan_C_Tasse@rush.edu

847-422-3414 ext. +1

Other Identifiers

CA-BO-CIP-0130

Identifier Type: -

Identifier Source: org_study_id