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Three-dimensional (3D) Printed Hemodialysis Vascular Model

Three-dimensional (3D) Printed Hemodialysis Vascular Model for Increased Precision of Cannulation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05096416
Enrollment
20
Registered
2021-10-27
Start date
2023-01-01
Completion date
2026-07-31
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Access Failure

Keywords

hemodialysis, Magnetic resonance angiography, three-dimensional (3D) printed hemodialysis vascular model, Vascular access complication

Brief summary

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.

Detailed description

Hemodialysis is the most common treatment for End Stage Renal Disease (ESRD). For an optimal renal replacement therapy, a patent vascular access (VA) is essential. The importance of good vascular access maintenance has been strongly supported by the guidelines (1). Various hinderances render this goal unachievable. A well-known cause of VA failure is access infiltration, which is usually overlooked in clinical practices (2). The calculated economic burden attributable to VA complication is between $16,864 -US$20,961 and more than 50% is due to access infiltration alone (3). Imaging has a pivotal pre- and post-operative role in evaluating vascular access complications. Imaging modalities such as ultrasound (US), Digital Subtraction Angiography (DSA) and Magnetic Resonance Angiography (MRA) are available but their use is limited due to the limited view of plane available for visualization of vessel anatomy(4) and because of the deleterious side effects of the contrast agents used (5,6). Contrast enhanced Magnetic Resonance Angiography (MRA) provides an excellent means of imaging the vasculature (7) which can be reconstructed in a three- dimensional(3D) print. The skill set of dialysis technician nurses play a considerable role in achieving successful cannulation of the fistula. Due oftentimes to complicated vascular anatomy, cannulation based on cutaneous anatomic landmarks and physical examination can be deceiving. Even a minor error in cannulation can impair access longevity(3). The 3D image reconstruction provides a practical solution to generate a 3D VA model which can be used by the procedurists to cannulate the patients, reducing the complications and rate of re admissions. Overall, a significant reduction in the health care cost can be achieved

Interventions

DEVICEThe three-dimensional (3D) printed hemodialysis vascular model

The three-dimensional (3D) printed hemodialysis vascular model will be used as a guide map to cannulate the patients for hemodialysis and to minimize the risk of vascular access complications

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with a surgically placed hemodialysis access which has been used in the last 90 days or is being prepared for use in the next 90 days

Exclusion criteria

* Patients with only failed hemodialysis surgical access(es) that has/have not been used for \>90 days.

Design outcomes

Primary

MeasureTime frame
Quantify the number of dialysis treatments completed12 month

Secondary

MeasureTime frame
Quantify the number of vascular access interventions over a 12-month period compared to controls12 month
Quantify annual hospitalization rate compared to controls12 month

Countries

United States

Contacts

Primary ContactAndrew Siedlecki, MD
asiedlecki@bwh.harvard.edu+13148092879
Backup ContactAliza Anwar Memon, MBBS
aamemon@bwh.harvard.edu+13479824073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026