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

PatenSee Ltd.

Status: Enrolling

Conditions: Hemodialysis; Clinical Assessment

Treatments: Device: PatenSee System

Study type: Observational

Funder types: Industry

Identifiers

NCT07194395

CMAP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

AVF/G access

Description:

Patients with AV access (AVF/G) undergoing hemodialysis

Treatment:

Device: PatenSee System