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

August 26, 2026 updated by: University Medical Centre Ljubljana

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD
  • Phone Number: • 0038615228530
  • Email: dimitrij.kuhelj@kclj.si

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Venous Wall Thickness
Time Frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of Catheter Tip Positioning Using Sherlock 3CG
Time Frame: Immediately after insertion.
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
Time Frame: During procedure.
Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.
During procedure.
Procedure Duration
Time Frame: Time from skin puncture to successful catheter placement measured in minutes
Time from skin puncture to successful catheter placement.
Time from skin puncture to successful catheter placement measured in minutes
Incidence of Procedure-Related Complications
Time Frame: From insertion to 24 hours post-procedure and throughout catheter dwell time.

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
Time Frame: During procedure.
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
Time Frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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
Time Frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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
Time Frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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
Time Frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Centre Ljubljana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Oncology Ljubljana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dimitrij Kuhelj, MD, PhD, University Medical Center Ljubljana, Slovenia

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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