NCT07318025|Not Yet Recruiting
AVF-MONITOR POC Proof-of-concept Study
AVFMONITOR POC
AVF-MONITOR: a New Wearable Device for Vascular Access Monitoring in Hemodialysis Patients - Proof-of-concept Study
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AVFMONITOR POC
AVF-MONITOR: a New Wearable Device for Vascular Access Monitoring in Hemodialysis Patients - Proof-of-concept Study
Sponsor study identifier
interventional
6
1 country
1
Study Start
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a proof-of-concept single-centre prospective longitudinal interventional study performed in AVF patients under HD treatment at the Nephrology and Dialysis Department of the ASST-Papa Giovanni XXIII (Bergamo, Italy), involving the recording of AVF sounds by the AVF-MONITOR wearable prototype device. Participants will undergo a screening and enrollment visit, then follow-up visits for AVF sounds registration will be conducted once a week for all participants, prior to dialysis session, over a period of 8 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2025
Actual (reported)January 5, 2026
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
High-low peak ratio
Correlation between the high-low peak ratio (HLPR) calculated from acoustic recordings obtained using the AVF-MONITOR device (in Hz) and the gold standard electronic stethoscope (in Hz).
Once weekly for 8 weeks after the initial screening and enrollment visit
Patients undergoing HD with a functioning native AVF
Wearable non-invasive device consisting in an electronic platform that can acquire acoustic data by means of an analog microphone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ASST HPG23 - Unità di Nefrologia
Bergamo, BG, Italy
Poloni S, Soliveri L, Caroli A, Remuzzi A, Bozzetto M. The Potential of Sound Analysis to Reveal Hemodynamic Conditions of Arteriovenous Fistulae for Hemodialysis. Ann Biomed Eng. 2025 Jan;53(1):230-240. doi: 10.1007/s10439-024-03638-2. Epub 2024 Nov 1.
Poloni S, Condemi CG, Peracchi T, Caroli A, Remuzzi A, Bozzetto M. Leveraging Acoustic Analysis to Detect Arteriovenous Fistula Complications. Kidney360. 2025 Oct 1;6(10):1771-1779. doi: 10.34067/KID.0000000840. Epub 2025 Jun 10.
Giuseppe Remuzzi, M.D.
Istituto Di Ricerche Farmacologiche Mario Negri
First Submitted
December 19, 2025
First Posted
January 5, 2026
Study Start
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2026
Estimated (date passed)Contact the study team to confirm eligibility.
Roy-Chaudhury P, Arend L, Zhang J, Krishnamoorthy M, Wang Y, Banerjee R, Samaha A, Munda R. Neointimal hyperplasia in early arteriovenous fistula failure. Am J Kidney Dis. 2007 Nov;50(5):782-90. doi: 10.1053/j.ajkd.2007.07.019.
Bozzetto M, Poloni S, Caroli A, Curto D, D'Haeninck A, Vanommeslaeghe F, Gjorgjievski N, Remuzzi A. The use of AVF.SIM system for the surgical planning of arteriovenous fistulae in routine clinical practice. J Vasc Access. 2023 Sep;24(5):1061-1068. doi: 10.1177/11297298211062695. Epub 2022 Jan 6.
Caroli A, Manini S, Antiga L, Passera K, Ene-Iordache B, Rota S, Remuzzi G, Bode A, Leermakers J, van de Vosse FN, Vanholder R, Malovrh M, Tordoir J, Remuzzi A; ARCH project Consortium. Validation of a patient-specific hemodynamic computational model for surgical planning of vascular access in hemodialysis patients. Kidney Int. 2013 Dec;84(6):1237-45. doi: 10.1038/ki.2013.188. Epub 2013 May 29.
Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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