RECRUITING

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

Conditions

Hemodialysis Clinical Assessment Nephrology AV access Clinical monitoring of AV access Fistula AV graft

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-06-06

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07194395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Naama Barel

CONTACT

972-508341678

Naama.b@patensee.com

Adi Bigger Hoggeg

CONTACT

972-544708066

Adi.h@patensee.com

Study Locations (Sites)

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Collaborators and Investigators

Sponsor: PatenSee Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2025-06-06

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

Nephrology
AV access
Clinical monitoring of AV access
Fistula
AV graft

Additional Relevant MeSH Terms

Hemodialysis
Clinical Assessment