Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Recruiting
Observational Study
Hemodialysis
Clinical Assessment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 90 (estimated)
- Sponsor
- PatenSee Ltd. · Industry
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About This Trial
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 monito…
Trial Locations
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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 ap…
Contacts