Actively Recruiting
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study
Led by PatenSee Ltd. · Updated on 2025-09-26
90
Participants Needed
2
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adult aged 18 years or older
- Diagnosis of non-reversible kidney failure requiring long-term hemodialysis
- Functioning arteriovenous access (fistula or graft) in the upper extremity
- Able and willing to provide informed consent
- Willing and able to follow study requirements
You will not qualify if you...
- Active infection of the arteriovenous access
- AV access condition likely needing revision, such as symptomatic steal syndrome
- Expected to recover kidney function, receive kidney transplant, switch to peritoneal dialysis, or transfer care during the study
- Any reason investigator deems participant unsuitable for the study
- Medical or psychiatric illness that compromises ability to follow study requirements
- Participation in interventional study within 30 days prior that may affect study evaluation
- Female who is pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo clinical exams of their AV access by a qualified clinician following standard care, alongside contactless assessments using the PatenSee system.
Weekly visits for 6 weeks, then biweekly visits up to 12 months
Trial Site Locations
Total: 2 locations
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Meir Medical Center
Kfar Saba, Hasharon, Israel, 4428164
Not Yet Recruiting
Research Team
N
Naama Barel
A
Adi Bigger Hoggeg
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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