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Three-dimensional (3D) Printed Hemodialysis Vascular Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096416
Recruitment Status : Not yet recruiting
First Posted : October 27, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Andrew Michael Siedlecki, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Access Failure Device: The three-dimensional (3D) printed hemodialysis vascular model Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Three-dimensional (3D) Printed Hemodialysis Vascular Model for Increased Precision of Cannulation
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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.
Device: The 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




Primary Outcome Measures :
  1. Quantify the number of dialysis treatments completed [ Time Frame: 12 month ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096416


Contacts
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Contact: Andrew Siedlecki, MD +13148092879 asiedlecki@bwh.harvard.edu
Contact: Aliza Anwar Memon, MBBS +13479824073 aamemon@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Andrew Siedlecki, MD Brigham and Women's Hospital
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Responsible Party: Andrew Michael Siedlecki, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05096416    
Other Study ID Numbers: 2022P000658
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew Michael Siedlecki, Brigham and Women's Hospital:
hemodialysis
Magnetic resonance angiography
three-dimensional (3D) printed hemodialysis vascular model
Vascular access complication