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

NCT07325578 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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

The introducer placement is performed with the Epione device.

Sponsors & Collaborators

  • ICUREsearch

    collaborator INDUSTRY

  • Endpoint, LLC

    collaborator UNKNOWN

  • Precision IO Group

    lead INDUSTRY

Principal Investigators

  • Sean Tutton, MD · UC San Diego

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325578 on ClinicalTrials.gov