Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity

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Conditions studied: PICC Line Placement, Vessels; Anomaly

In brief

The insertion of peripherally inserted central catheters (PICCs) represents a minimally invasive and safe method for establishing long-term central venous access in patients requiring prolonged intravenous therapy, including chemotherapy, parenteral nutrition, and long-term antibiotic treatment. Ultrasound-guided cannulation of peripheral arm veins improves procedural success, reduces complications, and increases patient comfort compared with centrally inserted central catheters.Accurate positioning of the catheter tip at the cavo-atrial junction is essential for optimal catheter function and safety. The Sherlock 3CG Tip Confirmation System combines electromagnetic tracking with intracavitary electrocardiography (ECG) to enable real-time catheter tip navigation and positioning.The aim of this prospective clinical study is to evaluate the accuracy and safety of ultrasound-guided PICC insertion using the Sherlock 3CG system, as well as to assess the impact of PICC placement on venous wall integrity. Ultrasound examination of the target vein will be performed before catheter insertion and after catheter removal to evaluate potential vascular wall changes associated with catheter use. A chest X-ray examination will be performed after each catheter insertion to confirm final catheter tip position and to assess the accuracy of the navigation system.Fluoroscopic guidance will be used only in selected cases, such as patients with anatomical anomalies, previously known difficult vascular access, or unsuccessful standard catheter advancement.A total of 80 adult patients with a clinical indication for PICC placement will be enrolled over a three-year study period.

Key facts

Study ID

NCT07466472

Run by

University Medical Centre Ljubljana

People needed

80

Starts

2026-04-01

Expected to finish

2029-08-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• sinus rhythm
• medical indication
• suitable upper-extremity venous anatomy confirmed by ultrasound examination
• ability to provide written informed consent

You may not qualify if…

• Implanted cardiac pacing device
• Palliative care
• <18years old
• Local infection, skin lesion, or burn at the intended insertion site
• Severe coagulopathy contraindicating vascular access procedures
• Known allergy to catheter materials or local anesthetics used during the procedure
• Presenceof an implanted cardiac pacemaker or non-sinus cardiac rhythm preventing reliable intracavitary ECG guidance
• Anatomical abnormalities preventing safe PICC insertion
• Previous lymphadenectomy on the intended side
• Pre-existing venous thrombosis or significant venous wall pathology detected on baseline ultrasound

Full record on ClinicalTrials.gov

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