Magnetic Tracking and ECG-Guided Tip Confirmation System for PICCs

May 2, 2026 updated by: Zeyin Hu, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients who receiving PICC placement

Description

Inclusion Criteria:

  • cancer patients receiving PICC placement
  • High risk of PICC-related thrombosis(Evaluated by Caprini score ≥ 5)
  • Agree to receive PICC maintenance at the research hospital;
  • Sign the informed consent form

Exclusion Criteria:

  • PICC placed in the lower limb
  • Estimated survival time less than one month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cancer patients who undergo PICC placement (Caprini score ≥5)
Other: Sherlock 3CG Tip Confirmation System

Sherlock 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
one time catheterization rate
Time Frame: data will be collected on Day 1
data will be collected on Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
time for catheter tip positioning during catheterization
Time Frame: on Day 1
on Day 1
time for catheter tip adjustment after catheterization
Time Frame: on Day 1
on Day 1
rate of correct catheter tip positioning
Time Frame: on Day 1
on Day 1
rate of PICC-related complications
Time Frame: within 4 weeks after catheterization
within 4 weeks after catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 27, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SunYat-senU6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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