Epione-assisted introducer placement for percutaneous pelvic and spine procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UC San Diego
  San Diego, California, United States Recruiting
• Baptist Hospital Of Miami, Inc
  Miami, Florida, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Sean Tutton, MD — UC San Diego
• Study coordinator: Erin Meyers
• Email: clinical.department@quantumsurgical.com
• Phone: 305 731-2901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.