ESRDNCT03828253
Ellipsys Fistula for Hemodialysis Access
An observational study of ESRD, run by Richmond Vascular Center at 1 site in United States.
Trial summary
To report the outcomes of patients having percutaneous proximal radial artery fistula creation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 27 Aug 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Richmond Vascular Center
North Chesterfield, Virginia, 23236
Tricia Eichenlaub, RN, 804-864-8346, Teichenlaub@richmondvascularcenter.com
Brittani Lewis, 804-864-8346, Blewis@Richmondvascularcenter.com
About this study
Official title: Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access
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.
- Conditions
- ESRD
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow Volume
Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start27 Aug 2018
- Primary completion27 Aug 2019 (estimated)
- Study completion27 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Richmond Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Hull, MD, Principal investigator, Richmond Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828253
- Sponsor's protocol ID
- pAVF 1.0
- Status last verified
- Jan 2019
- First submitted
- 18 Oct 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access
- ClinicalTrials.gov ID
- NCT03828253
- Acronym / sponsor ID
- pAVF 1.0
- Conditions
- ESRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Richmond Vascular CenterUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 27 Aug 2019 (estimated)
- Study completion
- 27 Aug 2021 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To report the outcomes of patients having percutaneous proximal radial artery fistula creation.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood flow Volume
Time frame: 90 days
Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 32800660Hull 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Hull, MD principal investigator
Richmond Vascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Richmond Vascular Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tricia Eichenlaub, RN (804-864-8346, Teichenlaub@Richmondvascularcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow Volume (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.