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Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's

NCT05278507 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2023-01-23

No results posted yet for this study

Summary

This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and or difficulty/inability to infuse via a lumen or lumens of the catheter. The incidence of catheter-related bloodstream infection will also be tracked during the study.

Conditions

  • Peripherally Inserted Central Catheter

Interventions

DEVICE

Arrowga+rd Blue Advance Protection PICC Placement

The PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.

DEVICE

Sham Comparator PICC placement

The sham comparator PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.

Sponsors & Collaborators

  • Teleflex

    lead INDUSTRY

Principal Investigators

  • Xiao H Zhang · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • China

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 NCT05278507 on ClinicalTrials.gov