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Three-dimensional (3D) Printed Hemodialysis Vascular Model

ConditionHemodialysis Access Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • The three-dimensional (3D) printed hemodialysis vascular model

    Device

    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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quantify the number of dialysis treatments completed

Time frame
12 month

Secondary outcomes

1

Quantify the number of vascular access interventions over a 12-month period compared to controls

Time frame
12 month
2

Quantify annual hospitalization rate compared to controls

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: