Contactless Monitoring of AV Access in Hemodialysis Patients

This study is looking at a new device called the PatenSee System, which monitors your AV access (the connection made for hemodialysis) without touching it. We want to see how well the PatenSee System's results compare to the usual ways doctors check your AV access, which involve looking, listening, and feeling it. You might be able to join if you are an adult (18 or older) with kidney failure who needs regular hemodialysis and has a working AV access in your arm. The study aims to enroll 90 people. We will compare the PatenSee System's readings with your doctor's assessments over 6 weeks to see if it provides similar information.

Study design
This is an observational study, meaning it watches what happens without giving new treatments. It plans to include 90 participants.
What's involved
You would have a standard clinical exam of your AV access, followed by weekly assessments with the PatenSee System for 6 weeks, and then every two weeks for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed biweekly for up to one year from enrollment.

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NCT07194395

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

Recruiting
Not specifiedAges 18+Observational
PatenSee Ltd.
~90 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:PatenSee System

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of "Look" assessment with PatenSee's relevant output
Measured over 6 weeks per patient
+1 more outcome measured
Hemodialysis
Clinical Assessment
2 sites across 2 states
Michigan1
Hasharon1

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  • Comparison of "Look" assessment with PatenSee's relevant output6 weeks per patient

    Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring

  • Comparison of "Listen & Feel" assessments with PatenSee's relevant output6 weeks per patient

    Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured