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

NCT05105503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

  • Dialysis Access Malfunction
  • Dialysis; Complications

Interventions

DEVICE

Eko CORE Digital Stethoscope

The digital stethoscope will be used to take 9 recordings around each subject's maturing AVF once per week until study participation is over

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Eko Devices, Inc.

    lead INDUSTRY

Principal Investigators

  • Prabir Roy-Chaudhury, MD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105503 on ClinicalTrials.gov