PICC Line PlacementNCT07466472
Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity
An observational study of PICC Line Placement and Vessels; Anomaly, run by University Medical Centre Ljubljana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PICC Line Placement, Vessels; Anomaly
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- sinus rhythm
- medical indication
- suitable upper-extremity venous anatomy confirmed by ultrasound examination
- ability to provide written informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD contact
Alen Mahmutović Assistant, Bsc, Msc in Nursing, RN, B.A.Sc., M.Sc. contact
About this study
Official title: 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.
Read the 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.
- Conditions
- PICC Line Placement, Vessels; Anomaly
- Keywords
- PICC, Sherlock 3CG, Vessels Anomaly, Vessel Wall, Intracavitary Electrocardiogram
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Venous Wall Thickness
Measured in milimeters by high-resolution ultrasound at the catheterized vein
Measured: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Secondary outcomes (9)
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.
Measured: Immediately after insertion.
Procedural Success Rate
Successful catheter placement defined as correct tip location at the cavo-atrial junction without the need for repositioning.
Measured: During procedure.
Procedure Duration
Time from skin puncture to successful catheter placement.
Measured: 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
Measured: 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.
Measured: During procedure.
Incidence of Endothelial Irregularities
Presence of abscence of irregularities in the venous intima assessed by ultrasound
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PICC Line PlacementStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Ljubljana
- Responsible party
- Sponsor
- Investigators
- Dimitrij Kuhelj, MD, PhD, Principal investigator, University Medical Center Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466472
- Sponsor's protocol ID
- 20250214
- Other IDs
- Medical Center Ljubljana
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of a Peripherally Inserted Central Catheter on Vascular Wall Integrity
- ClinicalTrials.gov ID
- NCT07466472
- Acronym / sponsor ID
- 20250214
- Conditions
- PICC Line Placement, Vessels; Anomaly
- Keywords
- PICC, Sherlock 3CG, Vessels Anomaly, Vessel Wall, Intracavitary Electrocardiogram
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Institute of Oncology Ljubljana
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- sinus rhythm
- medical indication
- suitable upper-extremity venous anatomy confirmed by ultrasound examination
- ability to provide written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Accuracy of Catheter Tip Positioning Using Sherlock 3CG
Time frame: Immediately after insertion.
Procedural Success Rate
Time frame: During procedure.
Procedure Duration
Time frame: 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.
Need for Fluoroscopy Guidance
Time frame: 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).
Incidence of Perivascular Edema
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
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
Time frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD contact
Alen Mahmutović Assistant, Bsc, Msc in Nursing, RN, B.A.Sc., M.Sc. contact
Dimitrij Kuhelj, MD, PhD principal investigator
University Medical Center Ljubljana, Slovenia
Questions about this trial
What is this clinical trial studying?
An observational study of PICC Line Placement and Vessels; Anomaly, run by University Medical Centre Ljubljana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrij Kuhelj Associate Professor MD, Senior Consultant, MD, PhD (• 0038615228530, dimitrij.kuhelj@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Venous Wall Thickness (time frame: Baseline (pre-insertion) to immediately after catheter removal (up to several weeks depending on catheter dwell time).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.