Clinical trial NCT03879161: A Percutaneous Ultrasound Device With Needle Guide for Vascular Access
Official title: A Percutaneous Ultrasound Device With Needle Guide for Vascular Access
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Vascular Access
Keywords: Ultrasound
Femoral Artery
Intra-arterial
Catheterization
Liver Neoplasms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Perceptive Navigation LLC
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female participants, 18 years of age or older at the time of enrollment.
* Participants meeting all medical conditions for percutaneous angiography.
* International Normalized Ratio (INR) \<1.3.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.

Exclusion Criteria:

* Fibrous tissue in access path.
* Active skin infection at the point of needle insertion.
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
* Use of antithrombotic medication.
* For participants taking warfarin or other anticoagulant medication, INR \>1.3.
* Participants who cannot tolerate mild sedation.
* Participants with the following laboratory values, unless approved by hematologist: Platelet count \<100,000/mL, Activated Partial Thromboplastin Time (APTT) \>39 sec or Prothrombin Time (PT) \>15 sec
* Pregnancy or lactation
* Patient is unable to comply with requirements of the procedure, i.e. holding breath
* Participation in an investigational trial within 30 days of enrollment.
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study.
* Participants who are uncooperative or cannot follow instructions.

Primary outcomes:
measure: Device Safety as assessed by number of participants with Minor Bleeding
timeFrame: Within 24 hours from intervention
measure: Device Safety as assessed by number of participants with Major Bleeding
timeFrame: Within 3 days from intervention
Secondary outcomes:
measure: Technical accuracy as assessed by number of attempts to reach target site
timeFrame: Within 1 hour from intervention
measure: Technical accuracy as assessed by percentage of first attempt accesses to target site
timeFrame: Within 1 hour from intervention
measure: Technical efficacy as assessed by procedure time (minutes)
timeFrame: Within 1 hour from intervention
measure: Technical efficacy as assessed by target access time (minutes)
timeFrame: Within 1 hour from intervention
measure: Technical efficacy as assessed by device usage time (minutes)
timeFrame: Within 1 hour from intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert Liddell, MD
role: PRINCIPAL_INVESTIGATOR
References: