U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorPrecision IO Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous procedure in the MSK structures of the pelvis and/or the spine
DeviceThe introducer placement is performed with the Epione device.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CT guidanceExperimental treatment 1 intervention
Group B: CBCT guidanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasability
Rate of successful insertions of the introducer with the assistance of the Epione device.
Time frame
5 monthsSecondary 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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov