HemodialysisNCT07194395
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
An observational study of Hemodialysis and Clinical Assessment, run by PatenSee Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Clinical Assessment
- What is being tested?
- PatenSee System
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2025to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary dialysis clinics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Lalathaksha Kumbar, MD, 3139162711, lkumbar1@hfhs.org
Lalathaksha Kumbar, MD
Israel1 site, 1 recruiting
- Not yet recruiting
Meir Medical Center
Kfar Saba, Hasharon, 4428164
Site contact, +97297471889, mekerenben@clalit.org.il
Irina Kenis, MD
About this study
Official title: 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 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.
Read the detailed description
For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.
- Conditions
- Hemodialysis, Clinical Assessment
- Being tested
- PatenSee System
- Keywords
- Nephrology, AV access, Clinical monitoring of AV access, Fistula, AV graft
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatenSee SystemDevice
Contactless AV access monitoring device
| Study group | Role | What they receive |
|---|---|---|
| AVF/G access | Patients with AV access (AVF/G) undergoing hemodialysis Receives: Device: PatenSee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of "Look" assessment with PatenSee's relevant output
Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring
Measured: 6 weeks per patient
Comparison of "Listen & Feel" assessments with PatenSee's relevant output
Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured
Measured: 6 weeks per patient
Secondary outcomes (3)
Functionality endpoint - Average time to conduct PatenSee scanning data capture
Average time to conduct PatenSee scanning data capture
Measured: Up to 12 months
Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned
Proportion (%) of participants on whom the PatenSee was used as planned
Measured: Up to 12 months
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements
Average number of weeks participants obtained PatenSee measurements
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start6 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PatenSee Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194395
- Sponsor's protocol ID
- CMAP-001
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07194395
- Acronym / sponsor ID
- CMAP-001
- Conditions
- Hemodialysis, Clinical Assessment
- Keywords
- Nephrology, AV access, Clinical monitoring of AV access, Fistula, AV graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- PatenSee Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVF/G access | – | Device: PatenSee SystemPatients with AV access (AVF/G) undergoing hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary dialysis clinics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatenSee SystemContactless AV access monitoring device | Device | AVF/G access |
Primary outcome
Comparison of "Look" assessment with PatenSee's relevant output
Time frame: 6 weeks per patient
Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring
Comparison of "Listen & Feel" assessments with PatenSee's relevant output
Time frame: 6 weeks per patient
Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured
3 secondary outcomes
Functionality endpoint - Average time to conduct PatenSee scanning data capture
Time frame: Up to 12 months
Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned
Time frame: Up to 12 months
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Clinical Assessment, run by PatenSee Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naama Barel (972-508341678, Naama.b@patensee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of "Look" assessment with PatenSee's relevant output (time frame: 6 weeks per patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.