This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system. Data captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.
For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.
Study Type
OBSERVATIONAL
Enrollment
90
Contactless AV access monitoring device
Henry Ford Hospital
Detroit, Michigan, United States
RECRUITINGMeir Medical Center
Kfar Saba, Hasharon, Israel
NOT_YET_RECRUITINGComparison of "Look" assessment with PatenSee's relevant output
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
Time frame: 6 weeks per patient
Comparison of "Listen & Feel" assessments with PatenSee's relevant output
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
Time frame: 6 weeks per patient
Functionality endpoint - Average time to conduct PatenSee scanning data capture
Average time to conduct PatenSee scanning data capture
Time frame: Up to 12 months
Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned
Proportion (%) of participants on whom the PatenSee was used as planned
Time frame: Up to 12 months
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements
Average number of weeks participants obtained PatenSee measurements
Time frame: Up to 12 months
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