RecruitingNCT07194395

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 to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients

Sponsor

PatenSee Ltd.

Enrollment

90 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

Hemodialysis Clinical Assessment

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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