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

NCT07194395 | Recruiting

• 1 other identifier: CMAP-001
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Hemodialysis; Clinical Assessment

Keywords

Nephrology; AV access; Clinical monitoring of AV access; Fistula; AV graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Functionality endpoint - 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

  Up to 12 months

• Functionality endpoint - Average number of weeks participants obtained PatenSee measurements

  Up to 12 months

Other Outcomes (2)

• Safety Endpoints - Assessment of device related AEs

  Up to 12 months

• Exploratory Endpoints - AV access data collection

  Up to 12 months

Study Arms (1)

AVF/G access

Patients with AV access (AVF/G) undergoing hemodialysis

Device: PatenSee System

Interventions

PatenSee System DEVICE

Contactless AV access monitoring device

AVF/G access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary dialysis clinics

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PatenSee Ltd.: lead

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Meir Medical Center

Kfar Saba, Hasharon, 4428164, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Naama Barel

CONTACT

972-508341678; Naama.b@patensee.com

Adi Bigger Hoggeg

CONTACT

972-544708066; Adi.h@patensee.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 26, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)