Recruiting

Epione Device

Sponsor:

Precision IO Group

Code:

NCT07325578

Conditions

Bone Tumor

Osteoporosis

Traumatic Fracture

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Bone Tumor

Osteoporosis

Traumatic Fracture

Study ID

NCT07325578

Start date

Apr 28, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CT guidance

The procedure is performed under CT guidance.

experimental: CBCT guidance

The procedure is performed under CBCT guidance.

Interventions

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

The introducer placement is performed with the Epione device.

Primary outcome measure

  • Feasability [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Erin Meyers

305 731-2901clinical.department@quantumsurgical.com

Marion Chassouant

448 19 40 50clinical.department@quantumsurgical.com

Locations

UC San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Sean Tutton, MD

858-249-0460stutton@health.ucsd.edu

Baptist Hospital Of Miami, Inc

Recruiting

Miami, Florida, United States, 33176

Contacts

Gina Landinez, MD

786-596-2373Gina.Landinez@baptisthealth.net

Principal Investigator:

Gina Landinez, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jordan Tasse, MD

847-422-3414Jordan_C_Tasse@rush.edu

Principal Investigator:

Jordan Tasse, MD

More Information

Sponsor

Precision IO Group

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • percutaneous procedure
  • robot assistance
  • bone procedure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Precision IO Group on 2026-07-20.