Magnetic Tracking and ECG-Guided Tip Confirmation System for PICCs

NCT07369427 | Recruiting

• 1 other identifier: SunYat-senU6
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Peripherally Inserted Central Catheters

Outcome Measures

Primary Outcomes (1)

• one time catheterization rate

  data will be collected on Day 1

Secondary Outcomes (4)

• time for catheter tip positioning during catheterization

  on Day 1

• time for catheter tip adjustment after catheterization

  on Day 1

• rate of correct catheter tip positioning

  on Day 1

• rate of PICC-related complications

  within 4 weeks after catheterization

Study Arms (1)

cancer patients who undergo PICC placement (Caprini score ≥5)

Other: Sherlock 3CG Tip Confirmation System

Interventions

Sherlock 3CG Tip Confirmation System OTHER

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.

cancer patients who undergo PICC placement (Caprini score ≥5)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients who receiving PICC placement

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Zeyin Hu, Master

CONTACT

+8615899954190; huzy@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Researcher

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)