Neoplasms

Digestive System Diseases

All Conditions

Liver Neoplasms

Hematinics

All Drugs and Chemicals

Liver Extracts

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access	NCT03879161	Vascular Access	Vu-Path™	18 Years -	Johns Hopkins 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 femoral artery