ClinicalTrials.gg
RecruitingNCT07325578EPIOSUpdated Jul 20, 2026

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

An interventional study of Percutaneous procedure in the MSK structures of the pelvis and/or the spine in Bone Tumor, Osteoporosis and Traumatic Fracture, sponsored by Precision IO Group. Recruiting at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Precision IO Group · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
22 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Bone Tumor
  • Osteoporosis
  • Traumatic Fracture

Keywords

  • percutaneous procedure
  • robot assistance
  • bone procedure
03

In context

Bone Neoplasms

258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.

This study's planned enrollment of 60 is above the median of 44 across 163 interventional studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

This is the only study on the registry with Precision IO Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Patients with 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    CT guidance

    The procedure is performed under CT guidance.

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

  • Experimental
    CBCT guidance

    The procedure is performed under CBCT guidance.

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

Interventions

  • DevicePercutaneous procedure in the MSK structures of the pelvis and/or the spine

    The introducer placement is performed with the Epione device.

06

What researchers measure

Primary outcomes

  1. Feasability

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

    Time frame: 5 months

Secondary outcomes

  1. Safety Adverse Event

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

    Time frame: 6 months

  2. Accuracy

    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).

    Time frame: 5 months

07

Study locations

3 of 3 sites recruiting
  • UC San Diego
    San Diego, California 92093, United States
    Recruiting
  • Baptist Hospital Of Miami, Inc
    Miami, Florida 33176, United States
    Recruiting
    • Gina Landinez, MD · ContactGina.Landinez@baptisthealth.net · 786-596-2373
    • Gina Landinez, MD · Principal investigator
    • Brian Shiro, MD · Sub investigator
    • Ripal Gandhi, MD · Sub investigator
    • Constantino Pena, MD · Sub investigator
    • Govindarajan Narayanan, MD · Sub investigator
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
    Recruiting
    • Jordan Tasse, MD · ContactJordan_C_Tasse@rush.edu · 847-422-3414
    • Rehan Riaz, MD · Sub investigator
    • Bulent Arslan, MD · Sub investigator
    • Jordan Tasse, MD · Principal investigator
    • Lisa Rauschert, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Age, Sex, Ethnicity, Race will be shared

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: by the end of the study

Access criteria: everyone, they will be described in the report and publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07325578
Lead sponsor
Precision IO Group
Collaborators
ICUREsearch, Endpoint, LLC
Responsible party
Sponsor
First posted
Jan 8, 2026
Start date
Apr 28, 2026
Primary completion
Jan 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

Erin Meyers
Contact
clinical.department@quantumsurgical.com
305 731-2901 ext. +1
Marion Chassouant
Contact
clinical.department@quantumsurgical.com
448 19 40 50 ext. +33
Sean Tutton, MD
principal investigator · UC San Diego

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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