PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 20, 2022

Primary Completion Date

July 29, 2024

Study Completion Date

July 29, 2024

Conditions
Chronic Kidney Disease stage3Chronic Kidney Disease stage4Chronic Kidney Disease Stage 5Poor Vascular Access
Interventions
DEVICE

PAVmed PortIO™ Intraosseous Infusion System

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.

Trial Locations (4)

Unknown

Cediul, Barranquilla

Sabbag Radiologos, Barranquilla

Cirulaser Andes, Bogotá

Centro Medico Imbanaco, Santiago de Cali

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PAVmed Inc.

INDUSTRY