Ultrasound Imaging for Vascular Access (CANSCAN Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Vexev Pty Ltd
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
What safety data exists for ultrasound imaging for vascular access?The research provided does not directly address safety data for ultrasound imaging specifically for vascular access. However, it discusses various robotic ultrasound systems and their applications in medical procedures, such as prostate surgery and brachytherapy, indicating ongoing evaluations and experiments. These studies suggest that robotic ultrasound systems are being tested for accuracy and feasibility, but specific safety data for vascular access is not detailed in the provided abstracts.14568
Is Robotic Tomographic Ultrasound Imaging a promising treatment for vascular access?Yes, Robotic Tomographic Ultrasound Imaging is promising because it combines ultrasound with robotics for high precision and repeatability, improves access to ultrasound in remote areas, and provides better image quality for medical diagnosis.245710
Do I need to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on ultrasound imaging, so it's unlikely that you'll need to stop your medications, but please confirm with the study team.
What data supports the idea that Ultrasound Imaging for Vascular Access is an effective treatment?The available research shows that using ultrasound imaging for vascular access, especially in hemodialysis patients, is effective because it helps detect problems early and avoid unnecessary invasive procedures. For example, point-of-care ultrasound (POCUS) allows clinicians to see the needle position and detect issues like blockages, which can prevent complications. This is better than traditional methods that might require more invasive techniques. Additionally, robotic ultrasound systems offer high precision and repeatability, which can improve the accuracy of procedures compared to manual methods.3591112
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 am 21 years old or older.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Imaging ArmExperimental Treatment1 Intervention
Robotic Tomographic Ultrasound Imaging is already approved in Australia for the following indications:
🇦🇺 Approved in Australia as Vexev Ultrasound Imaging System for:
- Arteriovenous Fistula Mapping Examinations
Find a clinic near you
Research locations nearbySelect from list below to view details:
USRC E Houston StreetSan Antonio, TX
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Who is running the clinical trial?
Vexev Pty LtdLead Sponsor
USRC Kidney ResearchCollaborator
References
Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments. [2016]To report the preliminary experimental results obtained with a robot-assisted transrectal ultrasound (TRUS)-guided prostate brachytherapy system.
High-speed ultrasound volumetric imaging system. II. Parallel processing and image display. [2008]For pt.I see ibid., vol.38, no.2, p.100-8 (1991). The authors describe the design, application, and evaluation of parallel processing to the high-speed volumetric ultrasound imaging system. The scanner produces images analogous to an optical camera or the human eye and supplies more information than conventional sonograms. Potential medical applications include improved anatomic visualization, tumor localization, and better assessment of cardiac function. The system uses pulse-echo phased array principles to steer a 2-D array transducer of 289 elements in a pyramidal scan format. Parallel processing in the receive mode produces 4992 scan lines at a rate of approximately 8 frames/s. Echo data for the scanned volume is presented online as projection images with depth perspective, stereoscopic pairs, or multiple tomographic images. The authors also describe the techniques developed for the online display of volumetric images on a conventional CRT oscilloscope and show preliminary volumetric images for each display mode.
3-D ultrasound guidance of surgical robotics using catheter transducers: feasibility study. [2008]The goal of this study was to test the feasibility of using a real-time 3-D (RT3D) ultrasound scanner with matrix array catheter probes to guide a surgical robot. We tested the accuracy of using 3-D catheter transducers with the 3-D measurement software of the scanner to direct automatically a robot arm that touched two needle tips together within a water tank and inside a vascular graft. RMS measurement error ranged from 2.4 to 3.4 mm for two catheter designs.
Subjective and objective quality assessment in wireless teleultrasonography imaging. [2020]Mobile Robotic teleultrasonography is an emerging technology that can be applied in different clinical settings for remote ultrasound scanning without the need of the expert at the point of care. Guaranteed medical image quality for diagnostic purposes and their delivery in bandwidth limited wireless environments is a challenging issue. In this paper we present some of the subjective and objective image analysis acquired from a robotic teleultrasonography system operated remotely by the expert to provide an assessment of these medical imaging measures for such advanced wireless telemedical system.
Robotic ultrasound systems in medicine. [2013]Robots ultrasound (RUS) can be defined as the combination of ultrasound imaging with a robotic system in medical interventions. With their potential for high precision, dexterity, and repeatability, robots are often uniquely suited for ultrasound integration. Although the field is relatively young, it has already generated a multitude of robotic systems for application in dozens of medical procedures. This paper reviews the robotic ultrasound systems that have been developed over the past two decades and describes their potential impact on modern medicine. The RUS projects reviewed include extracorporeal devices, needle guidance systems, and intraoperative systems.
Automatic localization of the da Vinci surgical instrument tips in 3-D transrectal ultrasound. [2016]Robot-assisted laparoscopic radical prostatectomy (RALRP) using the da Vinci surgical system is the current state-of-the-art treatment option for clinically confined prostate cancer. Given the limited field of view of the surgical site in RALRP, several groups have proposed the integration of transrectal ultrasound (TRUS) imaging in the surgical workflow to assist with accurate resection of the prostate and the sparing of the neurovascular bundles (NVBs). We previously introduced a robotic TRUS manipulator and a method for automatically tracking da Vinci surgical instruments with the TRUS imaging plane, in order to facilitate the integration of intraoperative TRUS in RALRP. Rapid and automatic registration of the kinematic frames of the da Vinci surgical system and the robotic TRUS probe manipulator is a critical component of the instrument tracking system. In this paper, we propose a fully automatic registration technique based on automatic 3-D TRUS localization of robot instrument tips pressed against the air-tissue boundary anterior to the prostate. The detection approach uses a multiscale filtering technique to identify and localize surgical instrument tips in the TRUS volume, and could also be used to detect other surface fiducials in 3-D ultrasound. Experiments have been performed using a tissue phantom and two ex vivo tissue samples to show the feasibility of the proposed methods. Also, an initial in vivo evaluation of the system has been carried out on a live anaesthetized dog with a da Vinci Si surgical system and a target registration error (defined as the root mean square distance of corresponding points after registration) of 2.68 mm has been achieved. Results show this method's accuracy and consistency for automatic registration of TRUS images to the da Vinci surgical system.
Feasibility of intercity and trans-Atlantic telerobotic remote ultrasound: assessment facilitated by a nondedicated bandwidth connection. [2022]We discuss the concept of ultrasound imaging at a distance by presenting the evaluation of a customized, lightweight, human-safe robotic arm for low-force, long-distance, telerobotic ultrasonography. We undertook intercity and trans-Atlantic telerobotic ultrasound simulation from master stations located in New York, New York and Munich, Germany, and imaged a phantom and a human volunteer located at a slave station in Burlington, Massachusetts, using standard Internet bandwidth
Augmented Reality Using Transurethral Ultrasound for Laparoscopic Radical Prostatectomy: Preclinical Evaluation. [2019]To guide the surgeon during laparoscopic or robot-assisted radical prostatectomy an innovative laparoscopic/ultrasound fusion platform was developed using a motorized 3-dimensional transurethral ultrasound probe. We present what is to our knowledge the first preclinical evaluation of 3-dimensional prostate visualization using transurethral ultrasound and the preliminary results of this new augmented reality.
On the reproducibility of expert-operated and robotic ultrasound acquisitions. [2019]We present the evaluation of the reproducibility of measurements performed using robotic ultrasound imaging in comparison with expert-operated sonography. Robotic imaging for interventional procedures may be a valuable contribution, but requires reproducibility for its acceptance in clinical routine. We study this by comparing repeated measurements based on robotic and expert-operated ultrasound imaging.
Telerobotic Sonography for Remote Diagnostic Imaging: Narrative Review of Current Developments and Clinical Applications. [2023]Access to sonographers and sonologists is limited in many communities around the world. Telerobotic sonography (robotic ultrasound) is a new technology to increase access to sonography, providing sonographers and sonologists the ability to manipulate an ultrasound probe from a distant location and remotely perform ultrasound examinations. This narrative review discusses the development of telerobotic ultrasound systems, clinical studies evaluating the feasibility and diagnostic accuracy of telerobotic sonography, and emerging use of telerobotic sonography in clinical settings. Telerobotic sonography provides an opportunity to provide real-time ultrasound examinations to underserviced rural and remote communities to increase equity in the delivery of diagnostic imaging.
Vascular access management of hemodialysis patients at the bedside using point-of-care ultrasound. [2022]When vascular access (VA) for hemodialysis is established using an autologous fistula or synthetic graft, repeated damage from needle insertion at each dialysis session can lead to thrombosis, resulting in vascular stenosis or occlusion that can cause poor blood removal, elevated venous pressure, and other impairments of blood flow. Compact, high-performance ultrasound devices have been developed in recent years. Such devices are used for point-of-care ultrasound (POCUS), which has been used on many occasions for emergency evaluation in the dialysis room and is becoming an important tool in VA management. POCUS provides a wealth of imaging information, such as needle position, whether the needle is inside or outside the blood vessel, and lesion position, width, and depth. This allows clinicians to detect VA problems early and take suitable measures, such as changing the cannulation site, thereby avoiding the need for unnecessary and highly invasive angiography or surgical procedures.
Results of a hemodialysis vascular access routine ultrasound surveillance protocol and frequency of surveillance guided pre-emptive access maintenance interventions. [2023]To evaluate the implementation of routine surveillance using ultrasound on hemodialysis vascular access (VA) outcomes and determine the number and frequency of corrective, surveillance-guided procedures performed.