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

N/ANot Yet RecruitingNCT07325578

Quantum Surgical60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bone Tumor Osteoporosis Traumatic Fracture

Interventions

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Feasability

Rate of successful insertions of the introducer with the assistance of the Epione device.

Time frame: 5 months

Secondary Outcomes

Safety Adverse Event

Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s))

Time frame: 6 months

Accuracy

Lateral and 3D deviations, being the distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory (lateral deviation) and the distance (mm) between the tip of the inserted introducer in its final position and the tip of the first planned trajectory (3D deviation).