Bone Tumor, Osteoporosis, Traumatic Fracture
Conditions
Keywords
percutaneous procedure, robot assistance, bone procedure
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.
Interventions
DEVICEPercutaneous procedure in the MSK structures of the pelvis and/or the spine
The introducer placement is performed with the Epione device.
Sponsors
Precision IO Group
ICUREsearch
Endpoint, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasability | 5 months | Rate of successful insertions of the introducer with the assistance of the Epione device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Adverse Event | 6 months | Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s)) |
| Accuracy | 5 months | 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). |
Countries
United States
Contacts
CONTACTErin Meyers
CONTACTMarion Chassouant
PRINCIPAL_INVESTIGATORSean Tutton, MD
UC San Diego
Outcome results
None listed