ClinicalTrials.gg
Status unknownNCT03828253Updated Feb 4, 2019

Ellipsys Fistula for Hemodialysis Access

An observational study in ESRD, sponsored by Richmond Vascular Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Richmond Vascular Center · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

Read the detailed description

The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.

02

Conditions studied

  • ESRD
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Richmond Vascular Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Recruitment of subjects will be from the current End Stage Renal disease patient population at Richmond Vascular Center and referrals from Nephrologists and Vascular Surgeons.

The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. We would like to consent previous Ellipsys® patients with appropriate medical records so that we may capture their data for outcomes reporting.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient age > 18 years or older
  • Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis
  • Adjacent vein diameter of > 2.0 mm at target anastomosis site and confirmed clinically significant outflow
  • Arterial lumen diameter of > 2.0 mm at target anastomosis site
  • Adequate collateral arterial perfusion: Barbeau test grade A through C
  • Radial artery -adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge via ultrasound

Exclusion criteria

Exclusion Criteria:

  • Target vessel that are \< 2mm is diameter
  • Distance between the target artery and vein > 1.5 mm
  • Edema of the upper extremity on the ipsilateral side
  • Barbeau test grade D
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Blood flow Volume

    Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Hull J, Deitrick J, Groome K. Maturation for Hemodialysis in the Ellipsys Post-Market Registry. J Vasc Interv Radiol. 2020 Sep;31(9):1373-1381. doi: 10.1016/j.jvir.2020.03.001. Epub 2020 Aug 14. PubMed 32800660 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03828253
Lead sponsor
Richmond Vascular Center
Responsible party
Sponsor
First posted
Feb 4, 2019
Start date
Aug 27, 2018
Primary completion
Aug 27, 2019 (estimated)
Completion
Aug 27, 2021 (estimated)
Last update
Feb 4, 2019

Study contacts

Tricia Eichenlaub, RN
Contact
Teichenlaub@Richmondvascularcenter.com
804-864-8346
Brittani Lewis
Contact
Blewis@Richmondvascularcenter.com
804-864-8346
Jeffrey Hull, MD
principal investigator · Richmond Vascular Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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