3D Printed Vascular Model for Hemodialysis

Overseen By Aliza Anwar Memon, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Failed hemodialysis access

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.

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 data supports the effectiveness of the 3D printed hemodialysis vascular model treatment?

Research shows that 3D-printed vascular models are highly accurate and can be customized to fit individual patients, which is important for successful hemodialysis. Additionally, a new 3D printing ink formulation for vascular grafts has been developed that is biocompatible and shows promising mechanical properties, similar to existing commercial options, but with better anti-fouling characteristics. ^{1 2 3 4 5}

Is the 3D printed vascular model for hemodialysis safe for humans?

Research shows that the 3D printed vascular grafts used for hemodialysis are biocompatible, meaning they are safe for the body and do not cause harmful reactions. They also do not induce cytotoxicity, which means they do not damage or kill cells. ^{1 2 3 5 6}

How does the 3D printed vascular model for hemodialysis differ from other treatments?

The 3D printed vascular model for hemodialysis is unique because it uses a novel ink formulation to create arteriovenous grafts that are biocompatible and customizable to the patient's vasculature, reducing the risk of graft failure. Unlike traditional grafts, these 3D printed models have excellent anti-fouling properties, preventing plasma protein adsorption and platelet adhesion, which can lead to thrombosis. ^{1 3 4 5 7}

Research Team

Andrew Siedlecki, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

Patients in this arm will have a three-dimensional (3D) printed vascular access model to assist the dialysis technician and nurse in cannulation.

Group II: Control arm Active Control 1 Intervention

Patients in this arm will have standard of care where they will be annulated by the palpation method by the dialysis technician and nurse.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

References

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

Three Dimensionally Printed Interactive Training Model for Kidney Transplantation. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Quality assurance in 3D-printing: A dimensional accuracy study of patient-specific 3D-printed vascular anatomical models. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The formulation and characterization of 3D printed grafts as vascular access for potential use in hemodialysis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Three-Dimensional Printing and Bioprinting in Renal Transplantation and Regenerative Medicine: Current Perspectives. [2023]

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

Optimization of FDM 3D printing process parameters to produce haemodialysis curcumin-loaded vascular grafts. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Blood Flow Within Bioengineered 3D Printed Vascular Constructs Using the Porcine Model. [2021]

7. Singapore pubmed.ncbi.nlm.nih.gov

Manufacturing flexible vascular models for cardiovascular surgery planning and endovascular procedure simulations: An approach to segmentation and post-processing with open-source software and end-user 3D printers. [2023]