U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
Recruiting
N/A
Interventional Study
Bone Tumor
Osteoporosis
Traumatic Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 60 (estimated)
- Sponsor
- Precision IO Group · Industry
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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.…
Trial Locations
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Eligibility Criteria
Inclusion 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…
Contacts