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

Part of paid clinical trials in San Diego, California.

Sponsor
Precision IO Group
Study ID
NCT07325578
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous procedure in the MSK structures of the pelvis and/or the spine — DEVICE
    The introducer placement is performed with the Epione device.

Study Details

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.

Key Dates

Start date
Apr 28, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: CT guidance
    The procedure is performed under CT guidance.
  • Experimental: CBCT guidance
    The procedure is performed under CBCT guidance.

Primary Outcome Measure

Feasability [ Time Frame: 5 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UC San DiegoSan DiegoCalifornia92093
Sean Tutton, MD
[email protected]
858-249-0460
Baptist Hospital Of Miami, IncMiamiFlorida33176
Gina Landinez, MD
[email protected]
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 CenterChicagoIllinois60612
Jordan Tasse, MD
[email protected]
847-422-3414
Rehan Riaz, MD (SUB_INVESTIGATOR)
Bulent Arslan, MD (SUB_INVESTIGATOR)
Jordan Tasse, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UC San Diego· San Diego, CABaptist Hospital Of Miami, Inc· Miami, FLRush University Medical Center· Chicago, IL

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