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

NCT06037265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4
  • Chronic Kidney Disease Stage 5
  • Poor 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.

Sponsors & Collaborators

  • PAVmed Inc.

    lead INDUSTRY

Principal Investigators

  • Gisella Lopez · Lucid Diagnostics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2024-07-29
Completion
2024-07-29
FDA Device
Yes

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037265 on ClinicalTrials.gov