RecruitingNot Applicable

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

United States, Israel90 participantsStarted 2025-06-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male and female adult patient aged ≥18 years old
✓. Patient has a non-reversible kidney failure that requires long-term hemodialysis
✓. Patient has a functioning AV access (AVF/G) in the upper extremity
✓. Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form
✓. Patient is willing and able to follow the requirements of the study

Exclusion criteria

✕. An active AV access infection
✕. An AV access condition that will likely require revision, e.g., symptomatic steal syndrome
✕. Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.
✕. Any reason per investigator's discretion for which the patient is not suitable for the study
✕. Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements
✕. Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints
✕. Female patient is pregnant or breastfeeding

What they're measuring

Comparison of "Look" assessment with PatenSee's relevant output

Timeframe: 6 weeks per patient

Comparison of "Listen & Feel" assessments with PatenSee's relevant output

Timeframe: 6 weeks per patient

Trial details

NCT IDNCT07194395

SponsorPatenSee Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Naama Barel

972-508341678 Naama.b@patensee.com

View on ClinicalTrials.gov More Hemodialysis trials