Sonavex, Inc.
This study is a prospective, single arm, multi-center two-stage feasibility study designed to evaluate the safety and effectiveness of the use of the EchoMap device to assist in traditional methods of AV fistula cannulation.
Inclusion Criteria: * Age \> 18 years but \< 85 years of age at the time of informed consent * Subjects who have received an upper extremity autologous arteriovenous fistula, which has been cleared for at least 1-needle cannulation * Subjects have a fistula with a history of miscannulation or requires an expert cannulator or have a new fistula that has not previously been cannulated * Subject is able to sign informed consent and able to participate in all testing associated with this clinical investigation Exclusion Criteria: * Age \<18 years old * Subject unable to sign informed consent. *…
EchoMap is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current Standard of Care cannulation methods.
Dialysis technicians will use the rope ladder or area cannulation technique (not button hole) to avoid repeat cannulation in the same location.
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Actual pay is set by the research site.
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