Ultrasound Imaging for Vascular Access

(CANSCAN Trial)

Overseen By Adrian Elorriaga, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vexev Pty Ltd

Disqualifiers: Upper limb injury, Open wounds, Vascular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether dialysis clinic staff can successfully use the Vexev Ultrasound Imaging System (also known as Robotic Tomographic Ultrasound Imaging) to scan blood vessels in the arm. The focus is on patients with chronic kidney disease (CKD) who need regular dialysis, as precise vein mapping is often necessary for their treatment. Participants must understand the study and have no serious arm injuries or surgeries that could interfere with scanning. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance dialysis care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on ultrasound imaging, so it's unlikely that your medications would need to be changed, but you should confirm with the study team.

What prior data suggests that the Vexev Ultrasound Imaging System is safe for vascular access?

Research has shown that the Robotic Tomographic Ultrasound Imaging system, such as the Vexev VxWave, is likely safe for humans. In one study, it successfully scanned 94% of the time and collected useful data 100% of the time, demonstrating its effectiveness and reliability.

This system helps manage blood vessel entry points, particularly benefiting individuals on dialysis. It employs robotic technology to capture detailed images of blood vessels, aiding in the maintenance of these entry points through regular monitoring.

Overall, no reports have linked harmful side effects directly to this imaging technology. Its "Not Applicable" phase suggests a focus on operational functionality rather than initial safety testing, indicating it is considered safe for broader use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Robotic Tomographic Ultrasound Imaging for vascular access because it offers a cutting-edge alternative to traditional methods like manual ultrasound guidance. This treatment is unique because it uses robotic technology to enhance precision and consistency, potentially reducing complications and improving success rates in obtaining vascular access. Unlike conventional methods that rely heavily on operator skill, this robotic approach could standardize the procedure, making it more accessible and reliable, especially in challenging cases.

What evidence suggests that the Vexev Ultrasound Imaging System is effective for vascular access?

Research has shown that the Vexev VxWave System, an advanced ultrasound imaging technology, effectively maps blood vessels in dialysis patients. Studies have found it successfully scans 94% of the time and consistently gathers all necessary information for planning vascular access. The system identified 98% of access options as feasible, demonstrating its reliability in real-world use. This trial will evaluate the Robotic Tomographic Ultrasound Imaging system, also known as the Vexev Ultrasound Imaging System, to determine its effectiveness in improving vascular access for dialysis patients. These promising results suggest that this imaging system could greatly enhance patient outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who need chronic renal replacement therapy or have chronic kidney disease (CKD) management. Participants must understand the study and consent to it.

Inclusion Criteria

I am referred for treatment of chronic kidney disease or for dialysis.

I understand the study's procedures and agree to participate.

I am 21 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Dialysis clinic staff perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System

12 weeks

Regular visits for imaging

Follow-up

Participants are monitored for the efficacy and feasibility of the ultrasound imaging system

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Tomographic Ultrasound Imaging

Trial Overview The study tests if dialysis clinic staff can use the Vexev Ultrasound Imaging System to map out blood vessels in the arm for patients with vascular access issues.

How Is the Trial Designed?

Group I: Imaging Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vexev Pty Ltd

Lead Sponsor

Trials

1

Recruited

120+

USRC Kidney Research

Collaborator

Trials

5

Recruited

3,000+

Published Research Related to This Trial

Robotic ultrasound (RUS) systems combine ultrasound imaging with robotic technology, offering high precision and repeatability in various medical procedures.

Over the past two decades, numerous RUS systems have been developed, including extracorporeal devices and needle guidance systems, which could significantly enhance the accuracy and effectiveness of medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic ultrasound systems in medicine. Priester, AM., Natarajan, S., Culjat, MO.[2013]

The study demonstrated the feasibility of using real-time 3-D ultrasound with matrix array catheter probes to accurately guide a surgical robot, achieving a root mean square (RMS) measurement error of 2.4 to 3.4 mm.

This technology was tested in both a water tank and inside a vascular graft, indicating its potential application in complex surgical environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3-D ultrasound guidance of surgical robotics using catheter transducers: feasibility study. Whitman, J., Fronheiser, MP., Smith, SW.[2008]

Point-of-care ultrasound (POCUS) is a valuable tool for managing vascular access in hemodialysis, providing real-time imaging that helps clinicians assess needle position and detect vascular issues early.

Using POCUS can prevent complications like thrombosis and stenosis by allowing for timely adjustments in cannulation techniques, potentially reducing the need for invasive procedures such as angiography or surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access management of hemodialysis patients at the bedside using point-of-care ultrasound. Onoue, A., Akiyama, T.[2022]

The robot-assisted transrectal ultrasound (TRUS)-guided prostate brachytherapy system successfully reached all clinically relevant locations in a prostate phantom, demonstrating its technical viability for precise needle placement.

The average placement errors for needle insertion were low, with a transverse error of 2 mm and a sagittal error of 2.5 mm, indicating that the system is inherently safe and effective, though further optimization is needed for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments. Fichtinger, G., Burdette, EC., Tanacs, A., et al.[2016]

The innovative laparoscopic/ultrasound fusion platform using a transurethral ultrasound probe successfully visualized the prostate in both 2D and 3D, demonstrating high-quality imaging and precise localization of passive markers on the prostate surface.

In tests on 74 prostate phantoms, the registration of laparoscopic and transurethral ultrasound was successful with a median root mean square error of 1.1 mm, indicating good precision, especially with the optimal use of 6 markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Reality Using Transurethral Ultrasound for Laparoscopic Radical Prostatectomy: Preclinical Evaluation. Lanchon, C., Custillon, G., Moreau-Gaudry, A., et al.[2019]

Telerobotic sonography allows healthcare professionals to perform ultrasound examinations remotely, which can significantly improve access to diagnostic imaging in underserved rural and remote communities.

Clinical studies indicate that telerobotic ultrasound systems are feasible and maintain diagnostic accuracy, making them a promising solution to address the shortage of sonographers and sonologists in many areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerobotic Sonography for Remote Diagnostic Imaging: Narrative Review of Current Developments and Clinical Applications. Adams, SJ., Burbridge, B., Obaid, H., et al.[2023]

The integration of transrectal ultrasound (TRUS) imaging with robot-assisted laparoscopic radical prostatectomy (RALRP) can enhance the accuracy of prostate resection and neurovascular bundle sparing, addressing the limited field of view in RALRP.

A new fully automatic registration technique for TRUS imaging was developed, achieving a target registration error of 2.68 mm in initial in vivo tests, demonstrating its potential for improving surgical precision in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic localization of the da Vinci surgical instrument tips in 3-D transrectal ultrasound. Mohareri, O., Ramezani, M., Adebar, TK., et al.[2016]

In a study of 223 hemodialysis patients over three years, routine ultrasound surveillance of vascular access (VA) led to high primary unassisted patency (PUP) rates of 83% at 12 months and 72% at 36 months, indicating effective monitoring and maintenance of access.

The study found that 65.5% of corrective procedures were pre-emptive, suggesting that ultrasound surveillance allows for timely interventions, although the overall frequency of these procedures was low, highlighting the potential for improved patient outcomes with further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a hemodialysis vascular access routine ultrasound surveillance protocol and frequency of surveillance guided pre-emptive access maintenance interventions. Giannikouris, IE., Georgiadis, GS., Giannakopoulos, T., et al.[2023]

The high-speed volumetric ultrasound imaging system utilizes parallel processing to generate detailed images at a rate of approximately 8 frames per second, providing more information than traditional sonograms.

This advanced imaging technique has potential medical applications such as improved visualization of anatomy, better tumor localization, and enhanced assessment of cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-speed ultrasound volumetric imaging system. II. Parallel processing and image display. von Ramm, OT., Smith, SW., Pavy, HR.[2008]

Mobile robotic teleultrasonography allows for remote ultrasound scanning, enabling expert assessment without being physically present at the point of care, which can enhance access to medical imaging in various clinical settings.

The study evaluates both subjective and objective image quality measures, addressing the challenges of maintaining diagnostic image quality in bandwidth-limited wireless environments, which is crucial for effective telemedicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective and objective quality assessment in wireless teleultrasonography imaging. Istepanian, RH., Philip, N., Martini, MG., et al.[2020]

Robotic ultrasound imaging provides more reproducible measurements compared to expert-operated sonography, as demonstrated by a study involving 4 healthy volunteers and a total of 144 measurements.

The robotic system's ability to automatically plan and execute imaging trajectories allows for consistent data collection, which is essential for effective clinical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the reproducibility of expert-operated and robotic ultrasound acquisitions. Kojcev, R., Khakzar, A., Fuerst, B., et al.[2019]

Long-distance telerobotic ultrasound imaging is feasible, as demonstrated by successful intercity and trans-Atlantic simulations using standard Internet bandwidth, allowing for remote echocardiography.

Experience with clinical ultrasound significantly improves the efficiency of operating the robotic arm, suggesting that while training is not mandatory, prior knowledge enhances performance in probe maneuvering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of intercity and trans-Atlantic telerobotic remote ultrasound: assessment facilitated by a nondedicated bandwidth connection. Sengupta, PP., Narula, N., Modesto, K., et al.[2022]

Citations

1. massdevice.com massdevice.com/vexev-robotic-ultrasound-study-meets-endpoints/

Vexev robotic ultrasound study meets endpoints Vexev and U.S. Renal Care today announced successful results from the CANSCAN trial of the VxWave robotic ultrasound imaging system.

2. prnewswire.com prnewswire.com/news-releases/vexevs-vxwave-system-successfully-meets-clinical-endpoints-in-landmark-study-evaluating-robotic-ultrasound-scanning-for-mapping-vascular-access-at-us-renal-care-dialysis-clinics-302609380.html

Vexev's VxWave System Successfully Meets Clinical ... VxWave Ultrasound Imaging System demonstrated 94% scanning success rate and 100% data adequacy rate for vascular access creation strategies ...

3. vir.com.vn vir.com.vn/vexevs-vxwave-succeeds-in-dialysis-vascular-mapping-trial-140444.html

Vexev's VxWave succeeds in dialysis vascular mapping trial 98% of Access Options2 determined feasible in patients. The VxWave System is a robotic tomographic ultrasound imaging system specifically ...

4. vascularnews.com vascularnews.com/enrolment-completed-in-canscan-trial-of-ultrasound-imaging-system-for-avf-mapping/

Enrolment completed in CANSCAN trial of ultrasound ... “The VxWave ultrasound system may remove one of the biggest hurdles in the creation of vascular access. Patients could have vascular mapping ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37997016/

Robotic tomographic ultrasound and artificial intelligence ... Robotic Tomographic Ultrasound is a novel approach to vascular access management that may reduce the risk of loss of functional access by regular monitoring ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/11297298231210019

Robotic tomographic ultrasound and artificial intelligence for ... Robotic Tomographic Ultrasound is a novel approach to vascular access management that may reduce the risk of loss of functional access by regular monitoring ...

7. vexev.com vexev.com/

Vexev – Vascular Imaging Reimagined Vascular Access is a crucial lifeline for patients on dialysis. Vexev has developed an advanced imaging solution to improve outcomes and lives.