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NCT05654103 · ClinicalTrials.gov registry record · NA

Comparing Surgical and Endovascular Arteriovenous Fistula Creation

A NA study of End Stage Renal Disease on Dialysis, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
2
Study locations

NCT05654103 is a NA study of End Stage Renal Disease on Dialysis that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 90 participants, above the 68-participant average among 9 other End Stage Renal Disease on Dialysis trials with a reported enrollment target (32% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT05654103, a NA study of End Stage Renal Disease on Dialysis, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
2
Study locations

Study Summary

Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF. This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.

Conditions Studied

End Stage Renal Disease on Dialysis

Interventions

  • DEVICE endoAVF
  • PROCEDURE surgAVF

Study Locations (2)

California

  • UCLA Division of Vascular and Endovascular Surgery Clinic - Los Angeles

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-11-20
Est. Completion 2028-01-01
Phase NA

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT05654103

The ClinicalTrials.gov registry entry for NCT05654103 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 68-participant average among 9 other End Stage Renal Disease on Dialysis trials with a reported enrollment target (32% higher). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with End Stage Renal Disease on Dialysis appearing as the primary indexed condition, and to 2 interventions - of which endoAVF is the first listed.

NCT05654103 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05654103 about?

NCT05654103 is a clinical study titled "Comparing Surgical and Endovascular Arteriovenous Fistula Creation". Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Until recently, AVFs w...

What is the current status of trial NCT05654103?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2024-11-20. Estimated completion is 2028-01-01.

What conditions does trial NCT05654103 study?

This clinical trial studies the following conditions: End Stage Renal Disease on Dialysis.

What interventions are being tested in trial NCT05654103?

The interventions under investigation include: endoAVF (DEVICE), surgAVF (PROCEDURE).

Who is sponsoring clinical trial NCT05654103?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05654103 being conducted?

This trial has 2 study locations across California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.