U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Purpose
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
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts 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 - Exclusion criteria linked to the freehand procedure have been discussed and validated
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CT guidance |
The procedure is performed under CT guidance. |
|
|
Experimental CBCT guidance |
The procedure is performed under CBCT guidance. |
|
Recruiting Locations
Baptist Hospital Of Miami, Inc
Miami, Florida 33176
Miami, Florida 33176
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
More Details
- Status
- Recruiting
- Sponsor
- Precision IO Group