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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
PatenSee Ltd.
Study ID
NCT07194395
Status
Recruiting
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Conditions

  • Clinical Assessment
  • Hemodialysis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PatenSee System — DEVICE
    Contactless AV access monitoring device

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: AVF/G access
    Patients with AV access (AVF/G) undergoing hemodialysis

Primary Outcome Measure

Comparison of "Look" assessment with PatenSee's relevant output [ Time Frame: 6 weeks per patient ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202
Lalathaksha Kumbar, MD
[email protected]
3139162711
Lalathaksha Kumbar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Henry Ford Hospital· Detroit, MI

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