Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2023-12-31

Brief Summary

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Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

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Detailed Description

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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

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End Stage Renal Failure on Dialysis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HeRO Graft

End stage renal disease patients who receive HeRO Graft implant for dialysis access

HeRO Graft implant for dialysis access

Intervention Type DEVICE

End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access

Interventions

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HeRO Graft implant for dialysis access

End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients eligible for HeRO Graft for dialysis access
* Age greater than 18 years old
* Able to give informed consent

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No