Contactless optical monitoring of dialysis fistulas and grafts with the PatenSee system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.