End Stage Renal Failure on DialysisNCT02164175
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
An observational study of End Stage Renal Failure on Dialysis, run by Merit Medical Systems, Inc. at 3 sites in United States.
Trial summary
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- HeRO Graft implant for dialysis access
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2013to Dec 2023
- How long will I take part?
- 5 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients eligible for HeRO Graft for dialysis access
Who may be able to join
- All patients eligible for HeRO Graft for dialysis access
- Age greater than 18 years old
- Able to give informed consent
Who cannot join
- Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
- Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor Research Institute
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
Sentara Medical Group Sentara Vascular Specialists
Norfolk, Virginia, 23507
About this study
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Read the detailed description
Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:
- Post-operative complications for HeRO Graft implantation
- Length of time between insertion and use of HeRO Graft
- Incidence of thrombosis
- Hospitalizations
- Incidence of infections and other adverse event occurrence
- Mortality
- Hemoglobin
- Kt/V
- pre-dialysis blood pressure
- post-dialysis blood pressure
- blood flow rate and
- dialysis flow rate
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- HeRO Graft implant for dialysis access
- Keywords
- HeRO Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeRO Graft implant for dialysis accessDevice
End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access
| Study group | Role | What they receive |
|---|---|---|
| HeRO Graft | End stage renal disease patients who receive HeRO Graft implant for dialysis access Receives: Device: HeRO Graft implant for dialysis access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Measured: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Secondary outcomes (2)
Adequacy of dialysis (Kt/V)
To evaluate if the adequacy of dialysis of participants using the HeRO Graft is better than the adequacy of dialysis of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Measured: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Infection rate
To evaluate if the infection rate of participants using the HeRO Graft is less than the infection rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Measured: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startDec 2013 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Company acquired and trial was not pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CryoLife, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Lawson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164175
- Sponsor's protocol ID
- HRG1301.000-M
- Status last verified
- May 2021
- First submitted
- 29 May 2014
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12.
PubMed 22580402Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22.
PubMed 19628360Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15.
PubMed 24428351
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT02164175
- Acronym / sponsor ID
- HRG1301.000-M
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- HeRO Graft
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company acquired and trial was not pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CryoLife, Inc.
- Study start
- Dec 2013 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- 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.
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Detailed description
Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:
- Post-operative complications for HeRO Graft implantation
- Length of time between insertion and use of HeRO Graft
- Incidence of thrombosis
- Hospitalizations
- Incidence of infections and other adverse event occurrence
- Mortality
- Hemoglobin
- Kt/V
- pre-dialysis blood pressure
- post-dialysis blood pressure
- blood flow rate and
- dialysis flow rate
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeRO Graft | – | Device: HeRO Graft implant for dialysis accessEnd stage renal disease patients who receive HeRO Graft implant for dialysis access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for HeRO Graft for dialysis access
Key inclusion criteria (3 listed)
- All patients eligible for HeRO Graft for dialysis access
- Age greater than 18 years old
- Able to give informed consent
Key exclusion criteria (2 listed)
- Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
- Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeRO Graft implant for dialysis accessEnd Stage Renal Disease patients who receive HeRO Graft implant for dialysis access | Device | HeRO Graft |
Primary outcome
Mortality
Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
2 secondary outcomes
Adequacy of dialysis (Kt/V)
Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Infection rate
Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 22580402Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12.
- Background: PubMed 19628360Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22.
- Background: PubMed 24428351Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15.
- HeRO Graft websiteLink provided by the sponsor.
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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 Lawson, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure on Dialysis, run by Merit Medical Systems, Inc. at 3 sites 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years). 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 NCT02164175, which also lists 3 linked publications.
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 10 May 2021.