NCT07194395

Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients

A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: PatenSee Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemodialysis
• Clinical Assessment

Interventions

Type	Name	Description
DEVICE	PatenSee System	Contactless AV access monitoring device

Timeline

• Start date: 2025-06-06
• Primary completion: 2026-06-01
• Completion: 2027-02-28
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

2 sites across 2 countries: United States, Israel