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NCT Number: NCT07325578

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

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.

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Key information

Conditions

Bone Tumor Bone Diseases Bone Diseases, Metabolic Bone Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Traumatic Fracture

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous procedure in the MSK structures of the pelvis and/or the spine

Device

The introducer placement is performed with the Epione device.

Primary outcomes

  1. Feasability

    Time frame: 5 months

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

Secondary outcomes

  1. Safety Adverse Event

    Time frame: 6 months

    Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s))

  2. Accuracy

    Time frame: 5 months

    Lateral and 3D deviations, being the distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory (lateral deviation) and the distance (mm) between the tip of the inserted introducer in its final position and the tip of the first planned trajectory (3D deviation).

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Meyers

CONTACT

[email protected]

305 731-2901 ext. +1

Marion Chassouant

CONTACT

[email protected]

448 19 40 50 ext. +33

Sponsors and collaborators

Lead sponsor

Precision IO Group

Industry

Collaborators

  • Endpoint, LLC
  • ICUREsearch

Registry information

Official study title

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

Acronym: EPIOS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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