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Evaluating the EPIONE Device for Bone and Spine Procedures

This study is evaluating the Epione device, which helps doctors place introducers (small tubes) during procedures on bones in the pelvis or spine. This device is being tested for conditions like bone tumors, osteoporosis, and traumatic fractures. The main goal is to see how often procedures using the Epione device are successful. You could be eligible if you are at least 22 years old and are scheduled for a CT- or CBCT-guided procedure in your pelvis or spine (not the neck) under general anesthesia. If you participate, the Epione device will be used for introducer placement, and you will have additional CT or CBCT scans during your procedure. The study plans to enroll 60 participants.

Study design
This is an interventional study evaluating a medical device, planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
If you participate, the Epione device will be used for introducer placement during your procedure, and you will have additional CT or CBCT scans. The study measures feasibility at 5 months.
Compensation
Not stated in the trial record.
Follow-up
The study measures feasibility at 5 months, which suggests a follow-up period of at least that long.

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NCT07325578

U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures

Recruiting
NAAges 22+Interventional
Precision IO Group
~60 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Percutaneous procedure in the MSK structures of the pelvis and/or the spine

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasability
Measured over 5 months

Conditions

Bone Tumor
Osteoporosis
Traumatic Fracture

Explore related trials

Bone NeoplasmOsteoporosisTraumatic Fracture

Where it's being run

3 sites across 3 states
California1
Florida1
Illinois1

Study leadership

  • Sean Tutton, MD · PRINCIPAL_INVESTIGATOR · UC San Diego

Who to contact

Erin Meyers
[email protected]
305 731-2901 · ext. +1
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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Feasability5 months

    Rate of successful insertions of the introducer with the assistance of the Epione device.