Actively Recruiting
Evaluation of the Epione Robotic System for Image-guided Percutaneous Musculoskeletal Procedures of the Pelvis and Spine in USA A Prospective Study on Feasibility, Safety and Accuracy
Led by Precision IO Group · Updated on 2026-06-04
60
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
P
Precision IO Group
Lead Sponsor
I
ICUREsearch
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of the Epione device to assist introducer placement during percutaneous procedures on musculoskeletal structures in the pelvis and spine of adults. This investigational device exemption aims to determine how often procedures using the Epione device are feasible compared to standard freehand placement. The study focuses on adults undergoing these procedures, excluding the cervical spine area, to evaluate safety, accuracy, and feasibility. Participants will have their planned procedures guided by either CT or cone beam CT (CBCT) imaging while using the Epione robotic system to place the introducer instead of the usual freehand method. The study includes two groups: one with CT guidance and another with CBCT guidance. Additional imaging scans will be performed during the procedure to assist with device placement and assessment. During the study, participants will be monitored for procedure feasibility over a 5-month period, with safety and accuracy also evaluated. Researchers will use imaging and clinical assessments to measure outcomes and track any adverse events. The overall participation includes signing consent, undergoing the procedure with the device, and follow-up monitoring to evaluate the device's performance and safety.
CONDITIONS
Brief 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 musculoskeletal 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 coagulation abnormalities or bleeding disorder
- Patients having an active infection on the day of intervention
- Patients having a history of previous surgery resulting in existing hardware precluding percutaneous approach
- Exclusion criteria linked to the freehand procedure have been discussed and validated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo the percutaneous musculoskeletal procedure of the pelvis and/or spine using the Epione device under CT or CBCT guidance.
1 procedure visit (in-person)
Duration - Up to 6 months
Participants are followed up to assess feasibility, safety, and accuracy of the procedure.
Approximately 5 to 6 follow-up visits
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
Actively Recruiting
Research Team
L
Laetitia Messner
M
Marion Chassouant
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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