Three-dimensional (3D) Printed Hemodialysis Vascular Model

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05096416
Status
Not Yet Recruiting

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Conditions

  • Hemodialysis Access Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Jul 2022
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control arm
    Patients in this arm will have standard of care where they will be annulated by the palpation method by the dialysis technician and nurse.
  • Experimental: Intervention arm
    Patients in this arm will have a three-dimensional (3D) printed vascular access model to assist the dialysis technician and nurse in cannulation.

Primary Outcome Measure

Quantify the number of dialysis treatments completed [ Time Frame: 12 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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