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

Assessment of the Impact of a Peripherally Inserted Central Catheter on Vascular Wall Integrity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vessels; Anomaly; PICC Line Placement

Detailed Description

Peripherally inserted central catheters (PICCs) have been widely used for many years as reliable central venous access devices in patients requiring prolonged intravenous therapy. Traditionally, catheter tip positioning is confirmed using fluoroscopy or chest radiography, which exposes patients to ionizing radiation and may increase procedural time and costs. Technological advances such as the Sherlock 3CG Tip Confirmation System allow real-time catheter navigation and tip positioning using electromagnetic tracking and intracavitary ECG.The primary objective of this prospective single-center clinical study is to evaluate the safety and effectiveness of ultrasound-guided PICC insertion using the Sherlock 3CG system. An additional objective is to assess the effect of PICC placement on venous wall integrity using ultrasound imaging before catheter insertion and after catheter removal.Adult patients (>18years) with sinus rhythm in the absence of an implanted cardiac pacing device and a medical indication for PICC placement, including chemotherapy, parenteral nutrition, or prolonged intravenous therapy, will be eligible for enrollment. After obtaining written informed consent, patients will undergo pre-procedural ultrasound examination to assess venous anatomy, vessel diameter, and baseline vascular wall characteristics.PICC insertion will be performed under sterile conditions using ultrasound guidance and the Seldinger technique. Cannulation will be performed in one of the upper-arm veins (basilic, brachial, or cephalic vein). Local anesthesia will be administered prior to venipuncture. Catheter tip navigation and positioning at the cavo-atrial junction will be performed using the Sherlock 3CG system with intracavitary ECG guidance.A chest X-ray examination will be performed after each catheter insertion to document the final catheter tip position and to evaluate the accuracy of the Sherlock 3CG system. Fluoroscopic guidance will not be routinely used but will be reserved for cases with suspected anatomical anomalies, previously documented difficult vascular access, or unsuccessful catheter advancement using the standard approach.Procedure duration, success rate, and any intra-procedural or post-procedural complications will be recorded. Following completion of therapy and catheter removal, patients will undergo repeat ultrasound examination to assess venous wall characteristics, including wall thickness, structural changes, and potential complications such as thrombosis or fibrosis. Baseline and follow-up findings will be compared.Participants will be followed according to clinical routine throughout catheter dwell time, and complications such as infection, thrombosis, catheter malfunction, or mechanical issues will be documented.The study will begin on March 1, 2026, with an estimated duration of three years. A total of 80 patients are planned to be enrolled.The results of this study are expected to provide evidence regarding the accuracy and safety of the Sherlock 3CG system, its impact on vascular wall integrity, and its role in optimizing vascular access procedures in clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD; Phone Number: • 0038615228530; Email: dimitrij.kuhelj@kclj.si
• Study Contact Backup: Name: Alen Mahmutović Assistant, Bsc, Msc in Nursing, RN, B.A.Sc., M.Sc.; Phone Number: 0038670649693; Email: alen.mahmutovic@zf.uni-lj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (>18years) with sinus rhythm in the absence of an implanted cardiac pacing device and a medical indications for PICC placement, including oncologic therapy, parenteral nutrition, or prolonged intravenous treatment, will be considered eligible for participation. All participants will provide written informed consent prior to enrollment.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Group; All patients will undergo ultrasound-guided PICC insertion using the Sherlock 3CG Tip Confirmation System, which combines electromagnetic tracking with intracavitary ECG guidance. • Post-procedural chest X-ray will be performed after each insertion to confirm catheter tip position and evaluate system accuracy. • Fluoroscopy will only be used in exceptional cases, such as known anatomical anomalies or previously documented difficult venous access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Venous Wall Thickness	Measured in milimeters by high-resolution ultrasound at the catheterized vein	Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Catheter Tip Positioning Using Sherlock 3CG	Accuracy of PICC tip placement will be evaluated by comparing the tip location predicted by the Sherlock 3CG system with chest X-ray confirmation performed after each insertion.	Immediately after insertion.
Procedural Success Rate	Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.	During procedure.
Procedure Duration	Time from skin puncture to successful catheter placement.	Time from skin puncture to successful catheter placement measured in minutes
Incidence of Procedure-Related Complications	Complications include: Arterial puncture; Hematoma; Malposition; Catheter dysfunction; Infection at insertion site; Symptomatic venous thrombosis; Pain requiring intervention	From insertion to 24 hours post-procedure and throughout catheter dwell time.
Need for Fluoroscopy Guidance	Fluoroscopy will be used only in cases of known difficult venous access or anatomical abnormalities. The frequency of fluoroscopy use will be recorded.	During procedure.
Incidence of Endothelial Irregularities	Presence of abscence of irregularities in the venous intima assessed by ultrasound	Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Incidence of Perivascular Edema	Presence of fluid accumulation around the vessel wall	Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Luminal Diameter Changes of the Catheterized Vein Assessed by Ultrasound	Changes in the luminal diameter (mm) of the catheterized vein measured by ultrasound before PICC insertion and after catheter removal. Measurements will be performed at the site of catheter insertion to evaluate potential structural changes of the vein associated with catheter placement.	Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Signs of Venous Thrombosis Assessed by Ultrasound	Presence of ultrasound-detected signs of venous thrombosis in the catheterized vein, including intraluminal thrombus formation, partial or complete vein occlusion, and absence or reduction of compressibility.	Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Institute of Oncology Ljubljana
• Investigators: Principal Investigator: Dimitrij Kuhelj, MD, PhD, University Medical Center Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PICC; Sherlock 3CG; Vessels Anomaly; Vessel Wall; Intracavitary Electrocardiogram
• Additional Relevant MeSH Terms: Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Congenital Abnormalities
• Other Study ID Numbers: 20250214; Medical Center Ljubljana (Other Identifier: Medical Center Ljubljana)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No