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?

This trial tests a new device called Epione, designed to assist doctors during specific bone procedures in the pelvis and spine. The goal is to determine if the Epione device simplifies and enhances the success of these procedures compared to the usual method. Participants will undergo their planned procedure with the Epione device and additional imaging scans. It suits adults approved for a guided procedure in the pelvis or spine and who are comfortable with general anesthesia. As an unphased trial, this study allows participants to contribute to innovative medical advancements that could improve future surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinator.

What prior data suggests that the Epione device is safe for use in musculo-skeletic procedures?

Research has shown that the Epione device, used in bone procedures, is generally safe for patients. One study found that using this device with CT scans to guide needle placement is both feasible and safe. This indicates that the device has been tested on people with positive results, and no major safety issues have emerged.

Another study examined the device's use with CBCT scans. This research also confirmed the device's safety in bone procedures. The studies suggest that patients tolerate the device well, with no serious side effects reported.

Overall, the Epione device has been tested with both CT and CBCT scans. The findings demonstrate its safety for use in procedures on the pelvis and spine. Patients considering participation in a trial with this device can feel confident about its safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Epione Device for bone conditions because it introduces two innovative guidance techniques: CT guidance and CBCT guidance. Unlike traditional methods, which may involve more invasive procedures or less precise imaging, these techniques allow for more accurate targeting of the treatment area. This precision can potentially improve outcomes by minimizing damage to surrounding tissues and enhancing the effectiveness of the treatment. The trial aims to determine if these advanced imaging technologies can offer a safer and more efficient approach for managing bone conditions.

What evidence suggests that the Epione device is effective for bone conditions?

This trial will test the EPIONE device under two guidance methods: CT guidance and CBCT guidance. Previous studies have shown that the EPIONE device holds promise for procedures involving the pelvis and spine. Specifically, when used with CT scans, the device successfully assisted in bone procedures without reported side effects, indicating its safety and effectiveness in instrument placement. For CBCT scans, the device is also considered safe and practical, though less detailed information is available. Overall, the EPIONE device is regarded as a reliable tool for enhancing the accuracy of these medical techniques. ^{1 3 6 7 8}

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07325578

U.S. Prospective Evaluation of EPIONE Device for ...

The procedure is performed under CBCT guidance. Intervention/Treatment, Device : Percutaneous procedure in the MSK structures of the pelvis and/ ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11241660/

Cone-Beam Computed Tomography (CBCT)

This review highlights the significance and current research status of the CBCT technique in diagnosis of dental bone defects, its advantages, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06376682

EPIBONE Study: a Prospective Study on Feasibility, Safety ...

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. Detailed Description.

4.

nature.com

nature.com/articles/s41598-024-84209-2

Short-term cone beam CT study on bone mass changes ...

This study aimed to investigate the change of peri-implant bone mass after touch-controlled, minimally invasive implantation in the mandibular first molar ...

5.

ctv.veeva.com

ctv.veeva.com/study/us-prospective-evaluation-of-epione-device-for-percutaneous-msk-procedures

US Prospective Evaluation of EPIONE Device for ...

The procedure is performed under CT guidance. Treatment: Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine.

6.

withpower.com

withpower.com/trial/phase-bone-neoplasms-2-2026-04232

Epione Device for Bone Conditions (EPIOS Trial)

Adults over 22 needing CT- or CBCT-guided musculoskeletal procedures in the pelvis or spine (excluding cervical area) under general anesthesia.

7.

quantumsurgical.com

quantumsurgical.com/news

Latest News & Upcoming Events from Quantum Surgical

Quantum Surgical obtains CE mark approval to treat patients with bone tumors and lesions using its Epione® robot. Montpellier, September 4th 2025– Quantum ...

8.

careacross.com

careacross.com/clinical-trials/trial/NCT06376682

EPIBONE Study: a Prospective Study on Feasibility, Safety ...

Summary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. Criteria for ...