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Study participants will be enrolled in the Device Arm and the Vu-Path™ Device will be used to access the femoral artery for intra-arterial chemoembolization.

Femoral arterial access in eligible participants will be performed using the Vu-Path™.

Vu-Path™

Robert Liddell, MD

This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will undergo the procedure of transcatheter arterial chemoembolization for primary or metastatic liver cancer, as part of participants' clinical care. The percutaneous ultrasound device with needle guide will be deployed in eligible participants at the beginning of the procedure for guiding a needle inside the femoral artery. Once the needle is inside the artery, then a guide wire is advanced inside the needle and vascular access is successfully obtained.

The study will identify whether this ultrasound-based device with needle guide is helpful for guiding a needle inside the femoral artery.

This NIH Small Business Innovation Research (SBIR)-funded study seeks to test a forward-viewing, ultrasound (US)-based device with needle guide for vascular access.

Access to large arteries is an indispensable step of any trans-arterial catheterization procedure. Surface US-guided vascular cannulation greatly improves first-pass success and reduces complications and is recommended as the preferred technique by numerous specialties and governmental agencies. Surface US-guided cannulation has several key limitations, including dependence on operator skills and experience. Safety and success of vascular access could be vastly improved with a single integrated imaging/interventional device with a small footprint that enables a single-hand operation of the US probe and visualizes the operating needle in real-time.

Reliable and accurate real-time image guidance for vascular access has the potential to appreciably impact public health by enhancing patient safety and convenience, improving procedural accuracy and increasing procedure throughput. Successful implementation has the potential to reduce care and complication costs across millions of vascular access procedures.

Vu-Path™ is a small footprint, US-based device with needle guide. It is a dual-lumen instrument with parallel US imaging and interventional lumens. The forward-viewing US transducer is located at the catheter tip and focused such that the tip of the needle in the interventional lumen, and all proximate structures, are always clearly visualized in real time throughout the procedure.

This is a first-in-human pilot study of the Vu-Path™ device, aiming to its establish clinical feasibility and safety for exemplary use.

A Percutaneous Ultrasound Device With Needle Guide for Vascular Access

Device Safety will be assessed by the number of participants experiencing minor bleeding resulting from vascular puncture. Minor bleeding is defined as either a) bleeding that requires no therapy, or has no consequences or, b) requires nominal therapy, or has no consequence or, c) includes overnight admission for observation only.

Device Safety will be assessed by the number of participants experiencing major bleeding. Major bleeding is defined as bleeding that either a) requires therapy and minor hospitalization (25-48 hours) or, b) requires major therapy, unplanned increase in level of care and prolonged hospitalization (\> 48 hours), or c) has permanent adverse sequelae or, d) results in death.

Percentage of first attempt accesses to target site.

Procedure time is defined as the total time needed for device procedure.

Target access time is defined as the total time needed from target visualization to target access.

Device usage time is defined as the total time needed for device use.

Perceptive Navigation LLC

National Heart, Lung, and Blood Institute (NHLBI)

Johns Hopkins University

Symptoms and General Pathology

Pain

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIVC application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. The vein imaging device will be opened with transilluminator, the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; the pain and fear levels before, during and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color, and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. Vein imaging will not be performed. No intervention will be carried out the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data will obtained on PIVC placement; the pain and fear levels before, during, and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Experimental group - Vascular imaging device with the infrared light group: Before PIVC, infrared light will be directed to the vein area and the procedure will be started after vein visibility is achieved.

Experimental group - Vascular access transillumination group: Before PIVC, a transilluminator will be inserted to the vein area and the procedure will be started after vein visibility is achieved

Vascular imaging

Yasemin Karacan, PhD

Türkkan Evrensel, Prof, PhD

Purpose: This study will be conducted on the effect of infrared light on PIVC procedure fear, procedure pain, and patient satisfaction in oncology patients receiving chemotherapy treatment. The investigators will implement the study during the insert on PIVC; the vascular imaging device with the infrared light group; the vascular access transillumination group; and the control group.

Design: This is a prospective, randomized controlled experimental study.

The population of the research will be cancer patients who applied to Bursa Uludag University Medical Faculty Hospital Oncology unit between June 2023 and July 2025. The population of the study will consist of patients who applied to the Chemotherapy Unit in Bursa Uludağ University Health Research and Application Center Hospital Oncology Polyclinic for outpatient treatment. It is aimed to reach all patients who agreed to participate in the study and who met the inclusion criteria of the study, rather than using the research sample selection method. However, this data does not show the number of patients who applied to the unit because of the repeated visits of the patients during the chemotherapy treatment process. For this reason, direct sample selection was not made in the study, and the sample calculation was made according to the number of patients registered in the unit and the results of previous research. Calculations were made using the "G.Power-3.17" program with 95% confidence, an effect size of 0.4, and a statistical test power of at least 80%. Accordingly, it was aimed to reach 126 patients, at least 42 in each group.However, since the losses will be ignored, it is aimed to reach 150 patients in total. The hypotheses of the research;

H0,1: In patients receiving chemotherapy, the vein imaging device has no effect on the successful PIVC procedure by determining the appropriate vein.

H1,1: In patients receiving chemotherapy, the vein imaging device has an effect on the successful PIVC procedure by determining the appropriate vein.

H2: Vascular imaging device has a lower value in terms of pain in the PIVC procedure in patients receiving chemotherapy.

H3: In patients receiving chemotherapy, the vascular imaging device has a lower level of fear in the PIVC procedure.

H4: In patients receiving chemotherapy, vascular imaging device is higher in terms of patient satisfaction in PIVC procedure.

Implementation of the study in the vascular imaging device with the infrared light group: The patient will be taken to the chemotherapy application chair and rested. The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Since it is stated in the literature that the placement of the peripheral intravenous catheter in the unused arm is important in preventing complications, the PIVC procedure will be performed in the arm that the patient does not actively use. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse . The vein imaging device will be opened with infrared light, the tourniquet will be connected, and the vein visibility will be re-evaluated by the research nurse. As soon as the turnstile is connected, the stopwatch will be started. Then the PIVC placement process will be started with the help of the device. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the branule. If there is no blood, the attempt will be considered unsuccessful. In unsuccessful cases, the PIVC attempt will be repeated up to two times in each patient. All procedures will be performed by a single research nurse to ignore the operator hand manipulation difference. Data obtained on PIVC placement; Vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIK application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion. The satisfaction levels in the form will be evaluated on a scale ranging from 0 to 10, with 0: none, 10: many, after the application. These data will be recorded in the data form on PIVC transaction satisfaction.

Implementation of the study in the vascular access transillumination group: The processes will be repeated exactly. Transilluminator will be used instead of infrared light.

Implementation of the study in the control group: The processes will be repeated exactly. No intervention will be made for vascular access.

This is a prospective, randomized controlled experimental study.

The intervention and measurements will carried out by the researcher (for hand manipulation standard) and the patients will discovered their own groups when intervention will applied to them. Because of the nature of the intervention, blinding will not be performed.

The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy

The Effect of Infrared Light Use on Pain, Fear, and Patient Satisfaction During Peripheral Intravenous Catheter (PIVC) Procedure in Oncology Patients Receiving Chemotherapy

Individual participant data (IPD) doesn't share any other researchers. Only research team will see data on IPD. After the data collection phase is completed and turned into a publication, other researchers can access the publication.

In this form, patients' satisfaction with the procedure will be evaluated using a visual comparison scale that can be graded from 1 to 10. It consists of questions created in line with the literature about how the nurse evaluates the patient's skills about the PIC procedure, how she evaluates your general PIC access experience, whether she sees herself as a patient with a history of DIFFICULT VASCULAR PATH, and whether the nurse who will perform PIC makes a comprehensive assessment of her veins (Eren and Çalışkan, 2021; Ramer et al., 2016). It includes minimum 0 point, maximum 10 points.

It is a one-dimensional scale used in the measurement of VAS pain. Among the one-dimensional scales used to determine the severity of pain in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Pain" and on the other end "Unbearable Pain" describing the most severe pain possible. The patient is asked to mark his pain on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

It is a one-dimensional scale used in the measurement of VAS fear. Among the one-dimensional scales used to determine the severity of fear in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Fear" and on the other end "Unbearable Fear" describing the most severe fear possible. The patient is asked to mark his/her fear on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access	NCT03879161	Vascular Access	Vu-Path™	18 Years -	Johns Hopkins University
The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy	NCT05892978	Pain Fear Needles Satisfaction, P...	Vascular imagin...	18 Years - 74 Years	Uludag University
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access	NCT03879161	Vascular Access	Vu-Path™	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for vascular access