PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System (NCT06037265) | Clinical Trial Compass
CompletedNot Applicable
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
Colombia15 participantsStarted 2022-01-20
Plain-language summary
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.
Who can participate
Age range22 Years – 99 Years
SexALL
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Inclusion criteria
✓. Subject is \> 22 years old
✓. Subject has grade 3 or higher CKD and is receiving or may receive renal replacement therapy with hemodialysis OR has poor/difficult vascular access.
✓. Subject does NOT need urgent or emergent vascular access;
✓. Subject, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
✓. Subject is willing and able to complete follow-up requirement
Exclusion criteria
✕. Fracture (within 6 months), bone tumor, or structural bone abnormality (such as osteogenesis imperfect, avascular necrosis, and severe osteoporosis) of the target bone
✕. Excessive overlying soft tissue, nerves, arteries, tendons or absence of anatomic landmarks at the target site
✕. Previous orthopedic procedure at or near the insertion site (e.g. artificial joint, rigid fixation hardware)
✕. IO access or attempted IO access in the target bone within 7 days
✕. Known or suspected allergy to any device component or materials contained in the device
✕. Local tissue factors preventing proper device stabilization and / or access including local infection, fragile tissue and absence of adequate or excessive overlying soft tissue.
What they're measuring
1
Primary Performance
Timeframe: Entire duration of Study an average of 2 years
2
Primary Safety
Timeframe: Entire duration of Study and average of 2 years
. Subject with known unstable cardiac disease (recent MI within 30 days, cardiac surgery within 6 months, unstable angina, severe aortic stenosis/regurgitation, severe congestive heart failure, severe mitral stenosis/regurgitation), uncontrolled diabetes (blood glucose \>240 mg/dl) or subjects on immunosuppressive medications (e.g. organ transplant patients)
✕. Subjects who are anticipated to receive infusion of blood or blood products, chemotherapeutic agents, hypertonic solutions, caustic agents or any agents known to harm bone marrow or cause bone marrow suppression such as azathioprine, procainamide, sulfasalazine via the test device.