Dialysis; Complications Clinical Trial
Official title:
Dialysis Access Monitoring Using a Digital Stethoscope-Based Deep Learning System
NCT number | NCT05105503 |
Other study ID # | 2021.10 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 23, 2022 |
Est. completion date | December 31, 2023 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolina Dialysis - Carrboro | Carrboro | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Eko Devices, Inc. | University of North Carolina, Chapel Hill |
United States,
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. — View Citation
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. Erratum In: Am J Kidney Dis. 2021 Apr;77(4):551. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Correlation between AI/ML model output and the AVF maturation status | A secondary aim of this study is to demonstrate whether Eko data scientists can create an artificial intelligence-machine learning (AI/ML) model that can detect changes over time in maturing AVFs that may predict the likelihood of AVF maturation or failure | 6 months | |
Secondary | Time frame of how soon after surgery the developed algorithm can accurately predict the likelihood of AVF failure-to-mature | An additional aim of this study is to determine how early after surgery the model can produce clinically acceptable notification of the failure-to-mature state | 6 months |
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