An observational study in PICC Line Placement and Vessels; Anomaly, sponsored by University Medical Centre Ljubljana. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University Medical Centre Ljubljana · Observational
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.
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.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's planned enrollment of 80 is below the median of 250 across 257 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in Venous Wall Thickness
Measured in milimeters by high-resolution ultrasound at the catheterized vein
Time frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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.
Time frame: Immediately after insertion.
Procedural Success Rate
Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.
Time frame: During procedure.
Procedure Duration
Time from skin puncture to successful catheter placement.
Time frame: 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
Time frame: 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.
Time frame: During procedure.
Incidence of Endothelial Irregularities
Presence of abscence of irregularities in the venous intima assessed by ultrasound
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 75 non-industry observational studies under Congenital Abnormalities, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 270. This study's planned 36 months is below that.
Counting every sponsor, half of 97 studies reached it within 49 months; a quarter within 23 and three quarters within 193.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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