3D Printed Vascular Model for Hemodialysis

AS
AA
Overseen ByAliza Anwar Memon, MBBS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people who need frequent dialysis, a treatment for kidney failure, by using a 3D printed model of blood vessels. The goal is to reduce complications from hemodialysis vascular access (HVA), which often leads to frequent hospital visits. Participants are divided into two groups: one will use the 3D printed hemodialysis vascular model to assist with treatment, while the other will continue with standard care. This trial targets individuals with a surgical access for dialysis that has been used recently or will be used soon. As an unphased trial, it offers a unique opportunity to explore innovative treatment methods that could improve the quality of life for dialysis patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the 3D printed vascular model is safe for hemodialysis?

Research has shown that 3D printed blood vessel models used for dialysis are safe and do not cause harmful reactions. Studies indicate that these models assist doctors in planning surgeries and are well-accepted by the body. No reports of serious side effects have emerged from using these models.

In summary, evidence suggests that 3D printed blood vessel models are safe and can be a useful tool in dialysis procedures.12345

Why are researchers excited about this trial?

Researchers are excited about the 3D printed vascular model for hemodialysis because it offers a new way to improve the accuracy of cannulation. Unlike the standard palpation method used by technicians and nurses to find the right spot for needle insertion, this innovative model provides a precise, visual guide that can potentially reduce errors and complications. The 3D model mimics the patient's unique vascular structure, allowing for personalized and optimized dialysis sessions. This could lead to better outcomes and greater comfort for patients undergoing hemodialysis.

What evidence suggests that the 3D printed vascular model is effective for hemodialysis?

Research has shown that 3D-printed models of blood vessels can greatly enhance medical procedures. These models enable doctors to visualize and plan surgeries with greater accuracy. In this trial, participants in the intervention arm will use a three-dimensional (3D) printed vascular access model to assist the dialysis technician and nurse in cannulation. Early studies suggest that 3D models can reduce complications such as fluid leakage into surrounding tissues. This technology creates a detailed model of a patient's blood vessels, aiding healthcare providers in avoiding issues during dialysis. While further research is necessary, the potential benefits of using these models in dialysis appear promising.13456

Who Is on the Research Team?

AS

Andrew Siedlecki, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for patients who have a surgically placed hemodialysis access used in the last 90 days or will be used soon. It's not for those whose only hemodialysis accesses have failed and haven't been used for over 90 days.

Inclusion Criteria

I have a dialysis access placed by surgery that's been used recently or will be soon.

Exclusion Criteria

My surgical access for hemodialysis has failed and hasn't been used for over 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or use a 3D printed vascular access model for cannulation

8 weeks
Weekly visits for dialysis sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • The three-dimensional (3D) printed hemodialysis vascular model
Trial Overview The study tests a new tool: a three-dimensional (3D) printed model of hemodialysis vascular access, created from MRI scans to help avoid infiltration during dialysis procedures.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Group II: Control armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

Potential Role of 3-Dimensional Printed Vascular Models in ...Three-dimensional (3D) modeling is a critical tool for proceduralists in preparation for surgical interventions. No such modeling is currently available for ...
3D Printed Vascular Model for HemodialysisWhat data supports the effectiveness of the 3D printed hemodialysis vascular model treatment? Research shows that 3D-printed vascular models are highly ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35773975/
Functioning tailor-made 3D-printed vascular graft for ...This kind of 3D-printed AVG is functioning in vivo, and our results realize personalized vascular implants. Further large-animal studies are ...
Current trends and outlook of 3D printing in vascular surgeryThis review aims to provide an in-depth introduction to 3D printing with an emphasis on its transformative influence on the field of vascular surgery.
Investigation of the Clinical Value of Three-Dimensional ...This study aimed to assess the clinical value of three-dimensional printed personalised vascular models (3DPPVMs) in assisting with the pre-operative planning ...
Elaboration and development of a realistic 3D printed ...Results: Vessels produced through indirect 3D printing latex dipping technique exhibited the best echogenicity, thickness, and mechanical ...
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