AVF-MONITOR POC Proof-of-concept Study
ConditionHemodyalysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
AVF MONITOR
DeviceWearable non-invasive device consisting in an electronic platform that can acquire acoustic data by means of an analog microphone.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Once weekly for 8 weeks after the initial screening and enrollment visitSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: