NCT06037265

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

First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System to Evaluate Safety and Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PAVmed Inc. · Industry
• Sex: All
• Age: 22 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open label, single arm, non-randomized, multicentric first in human clinical trial of the PortIO device for intraosseous infusion of fluids and/or medications for up to 60 days in subjects that meet the inclusion criteria. Both hospitalized patients as well as outpatients can be screened and, if appropriate, can be consented and enrolled into the study. They will have the PortIO device implanted by a qualified physician and then undergo prescribed infusions as needed and determined by the treating physician over either a 7-day or a 60-day period. The device will then be removed after the 7 days or 60 days of use and the subject followed up at 30 days after explant.

Conditions

• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Chronic Kidney Disease Stage 5
• Poor Vascular Access

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2023-09-14
• Last updated: 2025-06-27

Locations

4 sites across 1 country: Colombia

Regulatory

• FDA-regulated device study