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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,857 Total Patients Enrolled
Andrew Siedlecki, MDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a dialysis access placed by surgery that's been used recently or will be soon.My surgical access for hemodialysis has failed and hasn't been used for over 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm
- Group 2: Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this medical trial?
"The information on clinicaltrials.gov indicates that this particular medical trial is not presently searching for participants, as it was most recently updated on July 31st 2022. Nevertheless, 5 other studies which are currently enrolling patients remain available to prospective participants."
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