International Study to Monitor Arteriovenous Access in Adults on Hemodialysis Using the PatenSee Contactless Optical Device

What this Trial Is About

Researchers are conducting a prospective, non-interventional, single arm international study to evaluate the use of the PatenSee system for monitoring arteriovenous AV access in adult patients with kidney failure who require regular hemodialysis. The study aims to assess how data from the PatenSee device compares to standard clinical monitoring methods for AV access, such as physical examinations. Participants will undergo a clinical exam of their AV access by a qualified clinician following standard care procedures, known as Look, Listen, Feel. In addition, the PatenSee system will be used to assess the AV access weekly for the first 6 weeks and then every two weeks for up to one year. Additional data on imaging and complications related to the AV access will also be collected. Clinical decisions regarding the AV access will be based only on standard monitoring. During the study, participants will have regular assessments of their AV access with both clinical exams and the PatenSee system. Researchers will measure how well the PatenSee system matches the clinical exam assessments over 6 weeks, and track the functionality of the device over a year, including the time taken to capture data and the proportion of participants using the device as planned. The study will monitor participants for up to one year from enrollment, gathering important information on AV access health and device use.

Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients