Epione-assisted introducer placement for percutaneous pelvic and spine procedures
Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy
This will test whether the Epione device can help doctors place introducers during CT- or CBCT-guided percutaneous pelvic or spine procedures in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Precision IO Group Industry-sponsored |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Trial ID | NCT07325578 on ClinicalTrials.gov |
What this trial studies
This investigational device exemption tests the Epione robotic assistance for introducer placement during CT- or CBCT-guided percutaneous musculoskeletal procedures of the pelvis and thoraco-lumbar spine in adults. Participants will undergo their planned procedure under general anesthesia, with the Epione device used to guide introducer placement instead of freehand technique and with additional intra-procedural CT or CBCT imaging. The primary outcome is the rate of feasible procedures achieved with Epione-assisted introducer placement. The study enrolls adults aged 22 and older at three U.S. centers and follows routine coverage for standard-of-care costs.
Who should consider this trial
Good fit: Adults aged 22 or older who are approved for CT- or CBCT-guided percutaneous procedures in the pelvis or thoraco-lumbar spine under general anesthesia, can give informed consent, and have routine-cost coverage are ideal candidates.
Not a fit: Patients needing procedures outside the specified target areas (including the cervical spine), those who cannot undergo general anesthesia or extra CT/CBCT imaging, pregnant or breastfeeding individuals, or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Epione could make introducer placement more consistent and accurate, potentially reducing procedure time and procedural complications.
How similar studies have performed: Previous work with robot-assisted or image-guided systems has shown improved needle or instrument placement accuracy for spine and pelvic procedures, but the Epione device itself is newly investigational in the U.S.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California and 2 other locations
- UC San Diego — San Diego, California, United States (Not_yet_recruiting)
- Baptist Hospital Of Miami, Inc — Miami, Florida, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Sean Tutton, MD — UC San Diego
- Study coordinator: Laetitia Messner
- Email: clinical.department@quantumsurgical.com
- Phone: 305 731-2901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.