RecruitingNCT06898294

Assessment of Kidney Function by Electrical Impedance Tomography (EIT)

Assessment of Kidney Function by Self-administrable and Portable Electrical Impedance Tomography (EIT)


Sponsor

The University of Hong Kong

Enrollment

144 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The product under investigation is named Gense EIT-kidney device. This kidney device is a portable and non-invasive imaging modality capable of capturing the cross-sectional bioelectrical impedance distribution of the kidney at multiple current injection frequencies using electrical impedance tomography (EIT). Currently, the kidney device employs a band consisting of 16 equally distributed electrodes around the abdomen. The electrode band is connected to a control unit that switches the electrode stimulation and measurement pairs, then sends the collected measurement to a computational unit for image reconstruction. The images are then post-processed to extract functional kidney images for diagnosis. This kidney device can connect to an external screen, allowing the functional images to be produced and visualized.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria1

  • \- clinically diagnosed with CKD at different stages (stage 1-5) of the disease based on GFR measurement results Age: 18-90. Gender: Male/ Female

Exclusion Criteria9

  • ● Subjects with known kidney disease or abnormalities (for the control group).
  • Subjects who had any kind of kidney surgery or kidney transplantation.
  • Subjects with damaged skin on the abdomen.
  • Subjects with implanted electronic devices.
  • Subjects with spinal diseases/discomfort
  • Subjects who had any recent abdominal surgery
  • Pregnant women.
  • Obese subjects (BMI\>35).
  • Subjects with uncontrollable involuntary body movements such as degenerative disorders (e.g., Alzheimer's and Parkinson's disease); Seizure disorders (e.g., epilepsy, stroke, neuroleptic drugs); Neurological disorders (e.g., tardive dyskinesia and cerebral palsy, tremors, myoclonus, tics, athetosis, etc.)

Interventions

DIAGNOSTIC_TESTEIT kidney function assessment

The product under investigation is named Gense EIT-kidney device. This kidney device is a portable and non-invasive imaging modality capable of capturing the cross-sectional bioelectrical impedance distribution of the kidney at multiple current injection frequencies using electrical impedance tomography (EIT). Currently, the kidney device employs a band consisting of 16 equally distributed electrodes around the abdomen. The electrode band is connected to a control unit that switches the electrode stimulation and measurement pairs, then sends the collected measurement to a computational unit for image reconstruction. The images are then post-processed to extract functional kidney images for diagnosis. This kidney device has a large LED screen, allowing the functional images to be produced and visualized.


Locations(1)

Queen Mary Hospital, Hong Kong

Hong Kong, Hong Kong

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NCT06898294


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