Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPatenSee Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PatenSee System
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov