CompletedNot Applicable

Dialysis Access Monitoring Using a Digital Stethoscope-Based Deep Learning System

United States22 participantsStarted 2022-05-23

Plain-language summary

This study will enroll end-stage renal disease (ESRD) patients on hemodialysis with a maturing arteriovenous fistula (AVF) for hemodialysis access. A study staff member will mark with indelible ink on each participant's skin the three sites on the upper extremity where the Eko CORE digital stethoscope will be used to take sound recordings. 9 recordings will be taken (3 at each site) once per week during weekly dialysis treatments.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years or older * Potential subject is able and willing to give informed consent * End-stage renal disease, stage V, on active HD treatment * Participant has a maturing AVF that has not yet been cannulated * Participant is willing to have repeat Eko recordings taken weekly from the time of enrollment until the access is declared "mature and suitable for HD access" or "failed and unsuitable for HD access" Exclusion Criteria: * Younger than 18 years * Pregnant * Incarcerated * Unable and/or unwilling to give informed consent * Presence of an active infection or open wounds along potential access and data collection site * Unable to complete study activities according to the above schedule

What they're measuring

Development of deep learning-scale database of maturing AVF sounds.

Timeframe: 6 months

Trial details

NCT IDNCT05105503

SponsorEko Devices, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Dialysis Access Malfunction trials