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Intravascular Ultrasound for Kidney Failure (IVUS in ESRD Trial)

N/A

Recruiting

Led By Vipul Chitalia, MD PhD

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ESRD (end stage renal disease) patients at BMC (Boston Medical Center)

Undergoing a diagnostic fistulogram for the dialysis access malfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

IVUS in ESRD Trial Summary

This trial will test if IVUS is a better diagnostic tool than venography for central venous stenosis (CVS) in people with end stage renal disease.

Who is the study for?

This trial is for patients with end-stage renal disease on hemodialysis at Boston Medical Center who are experiencing dialysis access malfunctions and require a diagnostic fistulogram.Check my eligibility

What is being tested?

The study is testing the use of intravascular ultrasound (IVUS) as a potentially better way to diagnose central venous stenosis in comparison to the current standard, venography. IVUS may provide more detailed images of veins.See study design

What are the potential side effects?

While specific side effects are not listed, procedures like IVUS and venography might cause discomfort, bruising or bleeding at the insertion site, and very rarely, infection or allergic reactions.

IVUS in ESRD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced kidney disease and am a patient at Boston Medical Center.

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I am scheduled for a test to check my dialysis access for problems.

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I am currently on hemodialysis.

IVUS in ESRD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Extent of stenosis

Length of lesions

Morphology of lesion

IVUS in ESRD Trial Design

1Treatment groups

Experimental Treatment

Group I: IVUS and venography groupExperimental Treatment3 Interventions

Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

382 Previous Clinical Trials

869,349 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,136 Total Patients Enrolled

10 Trials studying Kidney Failure

10,720 Patients Enrolled for Kidney Failure

Vipul Chitalia, MD PhDPrincipal InvestigatorBoston Medical Center

Media Library

Intravascular ultrasound (IVUS) Clinical Trial Eligibility Overview. Trial Name: NCT04399941 — N/A

Kidney Failure Research Study Groups: IVUS and venography group

Kidney Failure Clinical Trial 2023: Intravascular ultrasound (IVUS) Highlights & Side Effects. Trial Name: NCT04399941 — N/A

Intravascular ultrasound (IVUS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04399941 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age cap for this study exceed eighty-five years?

"In accordance with the study's inclusion criteria, participants must be at least 18 years old and no older than 85."

Answered by AI

Who meets the prerequisites to take part in this experimentation?

"This clinical trial requires 50 participants aged 18 to 85, suffering from chronic kidney failure and receiving hemodialysis. Furthermore, all patients must have experienced a malfunction of their dialysis access."

Answered by AI

How many patients have consented to participating in this clinical exploration?

"Affirmative. Clinicaltrials.gov reveals that the research project, which commenced on August 3rd 2021, is currently looking for participants. 50 individuals need to be sourced from a single clinical site."

Answered by AI

Are there any opportunities to join this trial currently available?

"Affirmative. Clinicaltrials.gov records show the trial was first posted on August 3rd 2021 and subsequently updated on August 6th, 2022. As of now, 50 patients are being sought from 1 clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis

2021. "Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04399941.

All > Dialysis