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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Robotic Tomographic Ultrasound Imaging for vascular access?

Research shows that robotic ultrasound systems, which combine ultrasound imaging with robotic technology, have high precision and repeatability, making them suitable for medical procedures. Additionally, point-of-care ultrasound (POCUS) has been effective in managing vascular access for hemodialysis patients by providing detailed imaging information, helping to detect problems early and avoid invasive procedures. ^{1 2 3 4 5}

Is robotic ultrasound imaging safe for humans?

Robotic ultrasound systems have been used in various medical procedures, showing potential for high precision and safety. Initial evaluations, including experiments on tissue samples and a live anesthetized dog, suggest these systems are accurate and consistent, indicating a general safety in their application. ^{1 6 7 8 9}

How is the Robotic Tomographic Ultrasound Imaging treatment different from other treatments for vascular access?

Robotic Tomographic Ultrasound Imaging is unique because it combines ultrasound imaging with robotic technology, allowing for high precision and remote operation. This system can provide real-time, high-quality images from a distance, which is particularly beneficial for remote or underserved areas where access to specialists is limited. ^{1 7 10 11 12}

What is the purpose of this trial?

Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Robotic ultrasound systems in medicine. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

3-D ultrasound guidance of surgical robotics using catheter transducers: feasibility study. [2008]

3. Japan pubmed.ncbi.nlm.nih.gov

Vascular access management of hemodialysis patients at the bedside using point-of-care ultrasound. [2022]

4. United States 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

On the reproducibility of expert-operated and robotic ultrasound acquisitions. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Automatic localization of the da Vinci surgical instrument tips in 3-D transrectal ultrasound. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Subjective and objective quality assessment in wireless teleultrasonography imaging. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Augmented Reality Using Transurethral Ultrasound for Laparoscopic Radical Prostatectomy: Preclinical Evaluation. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

High-speed ultrasound volumetric imaging system. II. Parallel processing and image display. [2008]

11. England pubmed.ncbi.nlm.nih.gov

Telerobotic Sonography for Remote Diagnostic Imaging: Narrative Review of Current Developments and Clinical Applications. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Feasibility of intercity and trans-Atlantic telerobotic remote ultrasound: assessment facilitated by a nondedicated bandwidth connection. [2022]