Status:
RECRUITING
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Lead Sponsor:
PatenSee Ltd.
Conditions:
Hemodialysis
Clinical Assessment
Eligibility:
All Genders
18+ years
Brief 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 (A...
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 PatenS...
Eligibility Criteria
Inclusion
- Male and female adult patient aged ≥18 years old
- Patient has a non-reversible kidney failure that requires long-term hemodialysis
- Patient has a functioning AV access (AVF/G) 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
Exclusion
- An active AV access infection
- An AV access condition that will likely require revision, e.g., symptomatic steal syndrome
- Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.
- Any reason per investigator's discretion for which the patient is not suitable for the study
- Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements
- Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints
- Female patient is pregnant or breastfeeding
Key Trial Info
Start Date :
June 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07194395
Start Date
June 6 2025
End Date
February 28 2027
Last Update
September 26 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Meir Medical Center
Kfar Saba, Hasharon, Israel, 4428164