Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients

ConditionsHemodialysis Clinical Assessment

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

This trial does not accept healthy volunteers

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 population

Primary dialysis clinics

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PatenSee System
Device
Contactless AV access monitoring device

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: AVF/G access1 intervention

Trial outcomes

Primary outcomes

Comparison of "Look" assessment with PatenSee's relevant output

Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring

Time frame

6 weeks per patient

Comparison of "Listen & Feel" assessments with PatenSee's relevant output

Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured

Time frame

6 weeks per patient

Secondary outcomes

Functionality endpoint - Average time to conduct PatenSee scanning data capture

Average time to conduct PatenSee scanning data capture

Time frame

Up to 12 months

Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned

Proportion (%) of participants on whom the PatenSee was used as planned

Time frame

Up to 12 months

Functionality endpoint - Average number of weeks participants obtained PatenSee measurements

Average number of weeks participants obtained PatenSee measurements

Time frame

Up to 12 months

Other outcomes

Safety Endpoints - Assessment of device related AEs

Assessment of device related AEs

Time frame

Up to 12 months

Exploratory Endpoints - AV access data collection

Data collected in the study will be used to train PatenSee system's ability to alert on stenosis and other signs of AV access dysfunction processes.

Time frame

Up to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PatenSee Ltd.

Lead sponsor

Source ClinicalTrials.gov

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