NCT07194395 Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
| NCT ID | NCT07194395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PatenSee Ltd. |
| Condition | Hemodialysis |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-06-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07194395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07194395 currently recruiting?
Yes, NCT07194395 is actively recruiting participants. Contact the research team at Naama.b@patensee.com for enrollment information.
Where is the NCT07194395 trial being conducted?
This trial is being conducted at Detroit, United States, Kfar Saba, Israel.
Who is sponsoring the NCT07194395 clinical trial?
NCT07194395 is sponsored by PatenSee Ltd.. The trial plans to enroll 90 participants.