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3D Printed Vascular Model for Hemodialysis

N/A
Waitlist Available
Led By Andrew Siedlecki, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with only failed hemodialysis surgical access(es) that has/have not been used for more than 90 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

Summary

This trial sought to compare the accuracy of CEMRA-generated 3D models to conventional two-dimensional angiograms in HVA planning.

Who is the study for?
This trial is for patients who have a surgically placed hemodialysis access used in the last 90 days or will be used soon. It's not for those whose only hemodialysis accesses have failed and haven't been used for over 90 days.Check my eligibility
What is being tested?
The study tests a new tool: a three-dimensional (3D) printed model of hemodialysis vascular access, created from MRI scans to help avoid infiltration during dialysis procedures.See study design
What are the potential side effects?
Since this trial involves imaging and modeling rather than medication or invasive treatment, there are no direct side effects related to the intervention being studied.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My surgical access for hemodialysis has failed and hasn't been used for over 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantify the number of dialysis treatments completed
Secondary outcome measures
Quantify annual hospitalization rate compared to controls
Quantify the number of vascular access interventions over a 12-month period compared to controls

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Patients in this arm will have a three-dimensional (3D) printed vascular access model to assist the dialysis technician and nurse in cannulation.
Group II: Control armActive Control1 Intervention
Patients in this arm will have standard of care where they will be annulated by the palpation method by the dialysis technician and nurse.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,628 Previous Clinical Trials
11,474,620 Total Patients Enrolled
Andrew Siedlecki, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

The three-dimensional (3D) printed hemodialysis vascular model Clinical Trial Eligibility Overview. Trial Name: NCT05096416 — N/A
Hemodialysis Access Failure Research Study Groups: Control arm, Intervention arm
Hemodialysis Access Failure Clinical Trial 2023: The three-dimensional (3D) printed hemodialysis vascular model Highlights & Side Effects. Trial Name: NCT05096416 — N/A
The three-dimensional (3D) printed hemodialysis vascular model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096416 — N/A
~11 spots leftby Jul 2026
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