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

Merit Medical Systems

Status: Withdrawn

Conditions: End Stage Renal Failure on Dialysis

Treatments: Device: HeRO Graft implant for dialysis access

Study type: Observational

Funder types: Industry

Identifiers

NCT02164175

HRG1301.000-M

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

HeRO Graft

Description:

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

Treatment:

Device: HeRO Graft implant for dialysis access