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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVF/G access | Patients with AV access (AVF/G) undergoing hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PatenSee System | Device | Contactless AV access monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality endpoint - Average time to conduct PatenSee scanning data capture | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints - Assessment of device related AEs | Assessment of device related AEs | Up to 12 months |
| Exploratory Endpoints - AV access data collection | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Primary dialysis clinics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naama Barel | Contact | 972-508341678 | Naama.b@patensee.com | |
| Adi Bigger Hoggeg | Contact | 972-544708066 | Adi.h@patensee.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D005402 | Fistula |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 | Average number of weeks participants obtained PatenSee measurements | Up to 12 months |
| Up to 12 months |
| Meir Medical Center | Not yet recruiting | Kfar Saba | Hasharon | 4428164 | Israel |
|