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

Completed

Conditions studied: Dialysis Access Malfunction, Dialysis; Complications

In brief

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.

Key facts

Study ID

NCT05105503

Run by

Eko Devices, Inc.

People needed

22

Starts

2022-05-23

Expected to finish

2024-12-31

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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"

You may not qualify if…

• 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

Where it is running

• Carolina Dialysis - Carrboro — Carrboro, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.