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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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