An observational study in Hemodialysis and Clinical Assessment, sponsored by PatenSee Ltd.. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by PatenSee Ltd. · Observational
This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system.
Data captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.
For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's planned enrollment of 90 is close to the median of 97 across 56 observational studies indexed under Fistula.
Browse Fistula studies →This is the only study on the registry with PatenSee Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Primary dialysis clinics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with AV access (AVF/G) undergoing hemodialysis
Device: PatenSee System
Contactless AV access monitoring device
Comparison of "Look" assessment with PatenSee's relevant output
Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring
Time frame: 6 weeks per patient
Comparison of "Listen & Feel" assessments with PatenSee's relevant output
Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured
Time frame: 6 weeks per patient
Functionality endpoint - Average time to conduct PatenSee scanning data capture
Average time to conduct PatenSee scanning data capture
Time frame: Up to 12 months
Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned
Proportion (%) of participants on whom the PatenSee was used as planned
Time frame: Up to 12 months
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements
Average number of weeks participants obtained PatenSee measurements
Time frame: Up to 12 months
Safety Endpoints - Assessment of device related AEs
Assessment of device related AEs
Time frame: Up to 12 months
Exploratory Endpoints - AV access data collection
Data collected in the study will be used to train PatenSee system's ability to alert on stenosis and other signs of AV access dysfunction processes.
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.
Of 25 observational studies under Fistula, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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