Epione Device for Bone Conditions

(EPIOS Trial)

Not yet recruiting at 2 trial locations

Overseen By Marion Chassouant

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Quantum Surgical

Disqualifiers: General anesthesia contraindication, Breathing control issues, Pregnancy, Legal protection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sean Tutton, MD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

Adults over 22 needing CT- or CBCT-guided musculoskeletal procedures in the pelvis or spine (excluding cervical area) under general anesthesia. Participants must have signed an informed consent form and their insurance must cover routine costs of the standard procedure.

Inclusion Criteria

I have discussed and agreed to the freehand procedure requirements.

I am 22 years old or older.

I am approved for a CT- or CBCT-guided procedure in my pelvis or spine (not including the neck) under general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo percutaneous procedures with the assistance of the Epione device for introducer placement, including additional CT or CBCT scans.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of adverse events and accuracy of the procedure.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• EPIONE Device

Trial Overview

The trial is evaluating the EPIONE device for assisting with introducer placement during percutaneous procedures in pelvic and spinal structures. It compares standard freehand placement to using EPIONE, with additional imaging scans required.

How Is the Trial Designed?

Group I: CT guidance Experimental Treatment 1 Intervention

The procedure is performed under CT guidance.

Group II: CBCT guidance Experimental Treatment 1 Intervention

The procedure is performed under CBCT guidance.

Who Is Running the Clinical Trial?

Quantum Surgical

Lead Sponsor

Trials

4

Recruited

140+