Contactless optical monitoring of dialysis fistulas and grafts with the PatenSee system
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
This study will test a contactless camera-based system (PatenSee) to monitor arteriovenous fistulas or grafts in adults who receive regular hemodialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | PatenSee Ltd. Industry-sponsored |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Trial ID | NCT07194395 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional, single-arm international multicenter study enrolling up to 120 adults on maintenance hemodialysis with a functioning upper-extremity AV fistula or graft. Participants will receive standard clinical AV access exams by qualified staff and will also have the PatenSee system capture optical data weekly for 6 weeks and then every two weeks for up to 1 year. PatenSee data will be analyzed and compared against standard-of-care clinical monitoring and imaging, while all clinical decisions remain based on routine care. Additional information on imaging results and access-related complications will be collected to correlate with the device output.
Who should consider this trial
Good fit: Adults (≥18) with non-reversible kidney failure who are on long-term hemodialysis through a functioning upper-extremity AV fistula or graft and who can give informed consent and follow study procedures are ideal candidates.
Not a fit: Patients with an active AV access infection, those expected to have imminent access revision or to recover kidney function/receive a transplant or change dialysis modality, or those unable to comply with study visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the PatenSee system could provide a non-contact way to detect access problems earlier and complement routine exams, potentially reducing delays to intervention and clinic visits.
How similar studies have performed: Small pilot studies and research on camera- or optical-based monitoring of vascular access have shown promising early results, but large multicenter evaluations of commercial contactless systems remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Detroit, Michigan and 1 other locations
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Meir Medical Center — Kfar Saba, Hasharon, Israel (Not_yet_recruiting)
Study contacts
- Study coordinator: Naama Barel
- Email: Naama.b@patensee.com
- Phone: 972-508341678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.