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Official title U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
ClinicalTrials.gov ID: NCT07325578
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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
- linked to the freehand procedure have been discussed and validated
You likely 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...
- Pregnant or breast-feeding women,
- Patients subject to a legal protection measure,
See the full eligibility 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
- linked to the freehand procedure have been discussed and validated
- 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...
- Pregnant or breast-feeding women,
- Patients subject to a legal protection measure,
- Patients already participating in another conflicting treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Miami, Florida, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.