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

a study on Bone Tumor Osteoporosis Fracture Bone Cancer

Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Sean Tutton, MD (ucsd)

Description

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.

Official 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

Keywords

Bone Tumor, Osteoporosis, Traumatic Fracture, percutaneous procedure, robot assistance, bone procedure, Bone Neoplasms, Percutaneous procedure in the MSK structures of the pelvis and/or the spine, CT guidance, CBCT guidance

Eligibility

You can join if…

Open to people ages 22 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego accepting new patients
    San Diego California 92093 United States
  • Rush University Medical Center accepting new patients
    Chicago Illinois 60612 United States
  • Baptist Hospital Of Miami, Inc accepting new patients
    Miami Florida 33176 United States

Lead Scientist at University of California Health

  • Sean Tutton, MD (ucsd)
    Professor Of Clinical, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 63 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Precision IO Group
ID
NCT07325578
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated
Contact us about this trial