A Percutaneous Ultrasound Device With Needle Guide for Vascular Access

NCT03879161 | Withdrawn DMC

• 4 other identifiers: IRB00103043R42HL093879R44HL093879Z1822
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access

Keywords

Ultrasound; Femoral Artery; Intra-arterial; Catheterization; Liver Neoplasms

Outcome Measures

Primary Outcomes (2)

• Device Safety as assessed by number of participants with Minor Bleeding

  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.

  Within 24 hours from intervention

• Device Safety as assessed by number of participants with Major Bleeding

  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.

  Within 3 days from intervention

Secondary Outcomes (5)

• Technical accuracy as assessed by number of attempts to reach target site

  Within 1 hour from intervention

• Technical accuracy as assessed by percentage of first attempt accesses to target site

  Within 1 hour from intervention

• Technical efficacy as assessed by procedure time (minutes)

  Within 1 hour from intervention

• Technical efficacy as assessed by target access time (minutes)

  Within 1 hour from intervention

• Technical efficacy as assessed by device usage time (minutes)

  Within 1 hour from intervention

Study Arms (1)

Device Arm

EXPERIMENTAL

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.

Device: Vu-Path™

Interventions

Vu-Path™ DEVICE

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

Also known as: Percutaneous Ultrasound Device With Needle Guide

Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Perceptive Navigation LLC: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Robert Liddell, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 18, 2019
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 16, 2025

Record last verified: 2025-10

Locations

US (1)