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Recruiting NCT07194395

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

— Observational Hemodialysis Clinical Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PatenSee System.
Who it may be relevant to
Registry conditions: Hemodialysis, Clinical Assessment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device PatenSee System
    Contactless AV access monitoring device

Primary outcome measures

  • Comparison of "Look" assessment with PatenSee's relevant output [Time frame: 6 weeks per patient]
  • Comparison of "Listen & Feel" assessments with PatenSee's relevant output [Time frame: 6 weeks per patient]
Secondary outcome measures (3)
  • Functionality endpoint - 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 [Time frame: Up to 12 months]
  • Functionality endpoint - Average number of weeks participants obtained PatenSee measurements [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Henry Ford Hospital — Detroit
Israel · 1 center
  • Meir Medical Center — Kfar Saba

Identifiers

NCT: NCT07194395 · CMAP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗