Clinical Assessment, Hemodialysis
Conditions
Keywords
Nephrology, AV access, Clinical monitoring of AV access, Fistula, AV graft
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.
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
DEVICEPatenSee System
Contactless AV access monitoring device
Sponsors
PatenSee Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Look assessment with PatenSee's relevant output | 6 weeks per patient | 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 |
| Comparison of Listen & Feel assessments with PatenSee's relevant output | 6 weeks per patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality endpoint - Average number of weeks participants obtained PatenSee measurements | Up to 12 months | Average number of weeks participants obtained PatenSee measurements |
| Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned | Up to 12 months | Proportion (%) of participants on whom the PatenSee was used as planned |
| Functionality endpoint - Average time to conduct PatenSee scanning data capture | Up to 12 months | Average time to conduct PatenSee scanning data capture |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints - Assessment of device related AEs | Up to 12 months | Assessment of device related AEs |
| Exploratory Endpoints - AV access data collection | Up to 12 months | 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. |
Countries
Israel, United States
Contacts
Primary ContactNaama Barel
Backup ContactAdi Bigger Hoggeg
Outcome results
None listed