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Not Yet RecruitingNCT07369427

Magnetic Tracking and ECG-Guided Tip Confirmation System for PICCs

Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System for Placement of Peripherally Inserted Central Catheters

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
160 (estimated)
Sponsor
Sun Yat-sen University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This prospective study enrolled cancer patients who underwent peripherally inserted central catheter (PICC) placement at a tertiary care oncology hospital in Guangzhou between January 1st and May 30th, 2026. Data on catheterization outcomes and complications were collected to compare two tip positioning techniques: electromagnetic navigation tip positioning and traditional electrocardiogram (ECG)-guided positioning. The outcomes assessed included first-attempt catheterization success rate, tip positioning accuracy, catheterization procedure time, post-procedural catheter adjustment time, and the incidence of complications (thrombosis, infection, and catheter dysfunction) within 4 weeks post-catheterization.

Conditions

Interventions

TypeNameDescription
OTHERSherlock 3CG Tip Confirmation SystemSherlock 3CG Tip Confirmation System: An integrated system combining magnetic navigation tracking and ECG guidance. It dynamically confirms the tip's position relative to the target anatomical location (e.g., superior vena cava-right atrial junction) by real-time tracking of the catheter tip's spatial position via magnetic navigation and synchronously monitoring ECG signals (e.g., P-wave changes). Traditional ECG-Guided Tip Positioning Technology: Relying solely on ECG monitoring for guidance, it assists in determining the tip position via characteristic waveform changes in intracardiac ECG signals (e.g., changes in P-wave amplitude) derived from the catheter tip electrode as the tip approaches the target location, serving as a conventional positioning method.

Timeline

Start date
2026-01-30
Primary completion
2026-05-30
Completion
2026-06-30
First posted
2026-01-27
Last updated
2026-01-27

Source: ClinicalTrials.gov record NCT07369427. Inclusion in this directory is not an endorsement.