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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis; Clinical Assessment
• Intervention / Treatment: Device: PatenSee System

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Naama Barel; Phone Number: 972-508341678; Email: Naama.b@patensee.com
• Study Contact Backup: Name: Adi Bigger Hoggeg; Phone Number: 972-544708066; Email: Adi.h@patensee.com

Study Locations

• Israel
  • Hasharon
    • Kfar Saba, Hasharon, Israel, 4428164
      • Not yet recruiting
      • Meir Medical Center
      • Contact: Site contact; Phone Number: +97297471889; Email: mekerenben@clalit.org.il
      • Principal Investigator: Irina Kenis, MD
• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Lalathaksha Kumbar, MD; Phone Number: 3139162711; Email: lkumbar1@hfhs.org
      • Principal Investigator: Lalathaksha Kumbar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary dialysis clinics

Description

Inclusion Criteria:

1. Male and female adult patient aged ≥18 years old
2. Patient has a non-reversible kidney failure that requires long-term hemodialysis
3. Patient has a functioning AV access (AVF/G) in the upper extremity
4. Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form
5. Patient is willing and able to follow the requirements of the study

Exclusion Criteria:

1. An active AV access infection
2. An AV access condition that will likely require revision, e.g., symptomatic steal syndrome
3. Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.
4. Any reason per investigator's discretion for which the patient is not suitable for the study
5. Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements
6. Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints
7. Female patient is pregnant or breastfeeding

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AVF/G access; Patients with AV access (AVF/G) undergoing hemodialysis	Device: PatenSee System; Contactless AV access monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 weeks per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality endpoint - Average time to conduct PatenSee scanning data capture	Average time to conduct PatenSee scanning data capture	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	Up to 12 months
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements	Average number of weeks participants obtained PatenSee measurements	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints - Assessment of device related AEs	Assessment of device related AEs	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: PatenSee Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Estimated): September 26, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Fistula; AV graft; Nephrology; AV access; Clinical monitoring of AV access
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fistula
• Other Study ID Numbers: CMAP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No