Recruiting

PatenSee System

Sponsor:

PatenSee Ltd.

Code:

NCT07194395

Conditions

Hemodialysis

Clinical Assessment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PatenSee System

Study Details

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.

Conditions

Hemodialysis

Clinical Assessment

Study ID

NCT07194395

Start date

Jun 6, 2025

Status verified date

Sep, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

AVF/G access

Patients with AV access (AVF/G) undergoing hemodialysis

Interventions

PatenSee System

Contactless AV access monitoring device

Primary outcome measure

  • Comparison of "Look" assessment with PatenSee's relevant output [ Time Frame: 6 weeks per patient ]
  • Comparison of "Listen & Feel" assessments with PatenSee's relevant output [ Time Frame: 6 weeks per patient ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Lalathaksha Kumbar, MD

3139162711lkumbar1@hfhs.org

Principal Investigator:

Lalathaksha Kumbar, MD

More Information

Sponsor

PatenSee Ltd.

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • Nephrology
  • AV access
  • Clinical monitoring of AV access
  • Fistula
  • AV graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PatenSee Ltd. on 2025-09-26.