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AVF-MONITOR POC Proof-of-concept Study

NCT07318025 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

  • Hemodyalysis

Interventions

DEVICE

AVF MONITOR

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

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, M.D. · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Italy

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 NCT07318025 on ClinicalTrials.gov