Vascular AccessNCT03879161
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access
A study testing Vu-Path™ in people with Vascular Access, run by Johns Hopkins University at 1 site in United States.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access
- What is being tested?
- Vu-Path™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Vascular Access
- Being tested
- Vu-Path™
- Keywords
- Ultrasound, Femoral Artery, Intra-arterial, Catheterization, Liver Neoplasms
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vu-Path™Device
Also called Percutaneous Ultrasound Device With Needle Guide
Femoral arterial access in eligible participants will be performed using the Vu-Path™.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vu-Path™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 3 days from intervention
Secondary outcomes (5)
Technical accuracy as assessed by number of attempts to reach target site
Number of attempts to reach target site
Measured: Within 1 hour from intervention
Technical accuracy as assessed by percentage of first attempt accesses to target site
Percentage of first attempt accesses to target site.
Measured: Within 1 hour from intervention
Technical efficacy as assessed by procedure time (minutes)
Procedure time is defined as the total time needed for device procedure.
Measured: Within 1 hour from intervention
Technical efficacy as assessed by target access time (minutes)
Target access time is defined as the total time needed from target visualization to target access.
Measured: Within 1 hour from intervention
Technical efficacy as assessed by device usage time (minutes)
Device usage time is defined as the total time needed for device use.
Measured: Within 1 hour from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Expired IRB status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Perceptive Navigation LLC, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert Liddell, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879161
- Sponsor's protocol ID
- IRB00103043
- Other IDs
- R42HL093879, R44HL093879, Z1822
- Status last verified
- Oct 2025
- First submitted
- 28 Feb 2019
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Percutaneous Ultrasound Device With Needle Guide for Vascular Access
- ClinicalTrials.gov ID
- NCT03879161
- Acronym / sponsor ID
- IRB00103043
- Conditions
- Vascular Access
- Keywords
- Ultrasound, Femoral Artery, Intra-arterial, Catheterization, Liver Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Expired IRB status
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Perceptive Navigation LLC, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Mar 2019 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Vu-Path™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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vu-Path™Also: Percutaneous Ultrasound Device With Needle GuideFemoral arterial access in eligible participants will be performed using the Vu-Path™. | Device | Device Arm |
Primary outcome
Device Safety as assessed by number of participants with Minor Bleeding
Time frame: Within 24 hours from intervention
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 as assessed by number of participants with Major Bleeding
Time frame: Within 3 days from intervention
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.
5 secondary outcomes
Technical accuracy as assessed by number of attempts to reach target site
Time frame: Within 1 hour from intervention
Technical accuracy as assessed by percentage of first attempt accesses to target site
Time frame: Within 1 hour from intervention
Technical efficacy as assessed by procedure time (minutes)
Time frame: Within 1 hour from intervention
Technical efficacy as assessed by target access time (minutes)
Time frame: Within 1 hour from intervention
Technical efficacy as assessed by device usage time (minutes)
Time frame: Within 1 hour from intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
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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. This study is not recruiting at the moment.
Robert Liddell, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vu-Path™ in people with Vascular Access, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety as assessed by number of participants with Minor Bleeding (time frame: Within 24 hours from intervention). The study lists 2 primary outcomes in all. 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 16 Oct 2025.