Actively Recruiting
U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Led by Precision IO Group · Updated on 2026-05-05
60
Participants Needed
3
Research Sites
22 weeks
Total Duration
On this page
Sponsors
P
Precision IO Group
Lead Sponsor
I
ICUREsearch
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 22 years old or older
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
UC San Diego
San Diego, California, United States, 92093
Not Yet Recruiting
2
Baptist Hospital Of Miami, Inc
Miami, Florida, United States, 33176
Actively Recruiting
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
Research Team
L
Laetitia Messner
CONTACT
M
Marion Chassouant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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