Three-dimensional (3D) Printed Hemodialysis Vascular Model
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
August 2, 2022
July 1, 2022
3.6 years
October 15, 2021
July 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantify the number of dialysis treatments completed
12 month
Secondary Outcomes (2)
Quantify the number of vascular access interventions over a 12-month period compared to controls
12 month
Quantify annual hospitalization rate compared to controls
12 month
Study Arms (2)
Control arm
NO INTERVENTIONPatients in this arm will have standard of care where they will be annulated by the palpation method by the dialysis technician and nurse.
Intervention arm
EXPERIMENTALPatients in this arm will have a three-dimensional (3D) printed vascular access model to assist the dialysis technician and nurse in cannulation.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with only failed hemodialysis surgical access(es) that has/have not been used for \>90 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Siedlecki, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 27, 2021
Study Start
January 1, 2023
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share