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

NCT05105503 | Completed FDA Device

• 1 other identifier: 2021.10
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  The maturing AVFs sounds recorded during this study will be used to create a database used for AI/ML model development.

  6 months

Secondary Outcomes (2)

• Correlation between AI/ML model output and the AVF maturation status

  6 months

• Time frame of how soon after surgery the developed algorithm can accurately predict the likelihood of AVF failure-to-mature

  6 months

Study Arms (1)

Adults with AVFs currently in the process of maturing

Adults with ESRD who currently have a maturing AVF that has not yet been cannulated

Device: Eko CORE Digital Stethoscope

Interventions

Eko CORE Digital Stethoscope DEVICE

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

Adults with AVFs currently in the process of maturing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to enroll adults aged 18 years or older who have ESRD and have an AVF that is in the process of maturing.

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

Sponsors & Collaborators

• Eko Devices, Inc.: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Carolina Dialysis - Carrboro

Carrboro, North Carolina, 27510, United States

Location

Related Publications (3)

• Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.

  PMID: 32778223 BACKGROUND

• Bashar K, Conlon PJ, Kheirelseid EA, Aherne T, Walsh SR, Leahy A. Arteriovenous fistula in dialysis patients: Factors implicated in early and late AVF maturation failure. Surgeon. 2016 Oct;14(5):294-300. doi: 10.1016/j.surge.2016.02.001. Epub 2016 Mar 15.

  PMID: 26988630 BACKGROUND

• Murea M, Geary RL, Davis RP, Moossavi S. Vascular access for hemodialysis: A perpetual challenge. Semin Dial. 2019 Nov;32(6):527-534. doi: 10.1111/sdi.12828. Epub 2019 Jun 17.

  PMID: 31209966 BACKGROUND

Study Officials

• Prabir Roy-Chaudhury, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: May 23, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)