Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Start Date
6/6/2025
Completion Date
2/28/2027
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PatenSee System
Conditions
Locations
Henry Ford Hospital
Detroit, Michigan 48202
United States
Meir Medical Center
Kfar Saba, Hasharon 4428164
Israel