Actively Recruiting
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Led by PatenSee Ltd. · Updated on 2025-09-26
90
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and female adult patient aged 63 18 years old
- Patient has a non-reversible kidney failure that requires long-term hemodialysis
- Patient has a functioning AV access (arteriovenous fistula or graft) in the upper extremity
- Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form
- Patient is willing and able to follow the requirements of the study
You will not qualify if you...
- Active infection at the arteriovenous access site
- AV access condition likely requiring revision, such as symptomatic steal syndrome
- Expected recovery of kidney function, kidney transplant, transfer to peritoneal dialysis, or transfer to a non-study site during the study
- Any reason per investigator's discretion that makes the patient unsuitable for the study
- Any medical or psychiatric illness that may affect the patient's ability to follow study requirements
- Participation in an interventional study within 30 days before enrollment that could interfere with study evaluation
- Female patients who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Adi Bigger Hoggeg
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here