3D Ultrasound for Dialysis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the EchoMap device to determine if it can make dialysis easier and safer for people with certain types of fistulas, which are veins used for dialysis that can be hard to access. It compares the use of EchoMap alongside standard techniques to the usual methods alone. The trial seeks participants with an upper arm fistula that is either hard to use or new and who have previously experienced difficulties with needle placements. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance dialysis procedures.
What prior data suggests that the EchoMap device is safe for AV fistula cannulation?
Research has shown that ultrasound guidance, such as the EchoMap, can simplify locating veins for dialysis. In a small study, ultrasound improved needle placement accuracy in arteriovenous (AV) fistulas, which connect an artery and a vein for dialysis. Another study found that ultrasound reduced the likelihood of incorrect needle placement. No serious side effects were reported from using ultrasound guidance.
These findings suggest that the EchoMap, which employs 3D ultrasound, is generally well-tolerated and likely safe for guiding dialysis procedures. However, while these studies provide positive indications, discussing any concerns with the research team before joining a trial is always important.12345Why are researchers excited about this trial?
Researchers are excited about the EchoMap technique for dialysis because it introduces a new way to assist with cannulation, which is the process of inserting needles into a patient's veins. Unlike the standard of care that relies solely on visual and tactile techniques, EchoMap uses 3D ultrasound technology to guide the procedure, potentially making it more precise and less prone to errors. This could improve patient comfort and reduce complications associated with dialysis. By enhancing accuracy, EchoMap may lead to better outcomes and a more efficient dialysis process, which is why it is garnering attention.
What evidence suggests that the EchoMap device is effective for AV fistula cannulation?
Research has shown that 3D ultrasound techniques like EchoMap can assist in accurately placing needles for dialysis. In this trial, participants will be assigned to different groups to evaluate EchoMap's effectiveness. Studies have found that ultrasound can predict the long-term functionality of dialysis access points, such as AV fistulas. This is crucial because dialysis patients require reliable access for their treatments. One study demonstrated that ultrasound could visualize the fistula's structure and identify issues, revealing normal structure in about 81% of cases. This suggests that EchoMap, with its advanced imaging, might enhance the accuracy and safety of needle placements during dialysis sessions.678910
Are You a Good Fit for This Trial?
This trial is for people who are receiving dialysis and need needles placed into their AV fistula. Specific inclusion or exclusion criteria were not listed, but participants must be suitable for standard cannulation procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: Treatment
Participants undergo dialysis sessions with either Standard of Care or EchoMap support for up to 24 weeks
Stage 2: Treatment
Participants continue with dialysis sessions using either Standard of Care or EchoMap support
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EchoMap
Trial Overview
The study tests the EchoMap device, a 3D ultrasound tool used to help guide needle placement during hemodialysis. All participants receive this support in addition to usual care methods.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Subjects assigned to the EchoMap arm, for 12 dialysis sessions they will be cannulated using EchoMap in support of Standard of Care only. For
This group will be cannulated using EchoMap in support of Standard of Care for the 1st through 3rd dialysis session, and the 7th through 9th dialysis session. The second group will be cannulated using Standard of Care techniques for the 4th through 6th dialysis session, and again for the 10th through 12th session.
This group will be cannulated using Standard of Care techniques only for the first three dialysis sessions, and the 7th, 8th, and 9th dialysis session. The first group will be cannulated using EchoMap in support of standard techniques for the 4th through 6th dialysis session, and again for the 10th through 12th session.
Subjects will undergo standard cannulation practices only.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sonavex, Inc.
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
1.
healthmapsolutions.com
healthmapsolutions.com/articles/in-home-dialysis-better-outcomes-patient-experience-and-costsIn-Home Dialysis: Better Outcomes, Patient Experience ...
Despite research showing that home dialysis is as safe and effective as in-center treatment, only about 12% of ESRD dialysis patients are treated at home.
Development of open-source software for free-hand 3D ...
Results: The sono-angiograms showed identifiable characteristics that matched the fistulogram results in all five subjects. The PEM ranged between 42.8% and ...
Multiparametric ultrasound for upper extremity dialysis ...
The evolution of ultrasound (US) techniques has greatly improved the evaluation of many parameters in dialysis vascular access, include thrombosis, steal ...
Ultrasound predicts fistula success in dialysis patients
The investigators found that the three ultrasound assessments were effective in predicting the clinical maturation of the AVFs across a variety of patient ...
Application of ultrasonography in monitoring the complications ...
Ultrasound showed 72 cases (80.90%) had normal fistula structure, and 17 cases (19.10%) had complications. Ultrasound monitoring of brachial ...
Point-of-care ultrasound-guided cannulation versus ...
Results Eleven patients and seven nurses completed. Protocol adherence was 94.4%. Two miscannulations occurred, both during standard cannulation. Cannulation ...
LSI's Post
EchoMap uses 3D ultrasound and AI algorithms to help dialysis technicians without prior ultrasound experience visualize the target fistula or ...
Ultrasound guidance shown to improve cannulation ...
A small, randomised trial conducted in a UK dialysis unit has found ultrasound guidance can improve cannulation accuracy for AV fistulas.
Automated 3D ultrasound enables novice users to ...
DUS is resource-intensive and is associated with poor compliance rates in dialysis patients, ranging from 12% to 33%. Methods: EchoSure is an FDA-cleared 3D ...
Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF ...
This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall. Full description.
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