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Clinical Trials in Italy / NCT07318025
Starting soon Not applicable

AVF-MONITOR POC Proof-of-concept Study

NCT07318025 · tracked via the Priya Life Science Italy tracker
Sponsor
Mario Negri Institute for Pharmacological Research
Phase
Not applicable
Started
2026-03
Last updated
2026-01-14

Condition(s) studied

Hemodyalysis

Investigational drug(s) / intervention(s)

AVF MONITOR

AVF MONITOR: Wearable non-invasive device consisting in an electronic platform that can acquire acoustic data by means of an analog microphone.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Female and/or male aged ≥ 18. * Patients undergoing HD with a mature and functioning native AVF. Exclusion Criteria: * Patients with a history of complications related to the AVF in use. * Patients who use a graft or catheter to perform HD. * Patients with reduced life expectancy (less than 1 year).

Primary outcome measure(s)

  • High-low peak ratio — Once weekly for 8 weeks after the initial screening and enrollment visit
    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).

Trial sites (1)

FacilityCityRegionStatus
ASST HPG23 - Unità di Nefrologia Bergamo BG

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07318025 on ClinicalTrials.gov ↗ ← All trials in Italy