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Clinical Trial Summary

The investigation is a prospective cohort study, where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment. The overall objective is to assess the bioimpedance sensor's ability to detect local and systemic fluid accumulation. Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis. Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an "intensive" dialysis treatment regime, due to severe overhydration.


Clinical Trial Description

In Sub-investigation A, patients will be monitored for at least 10 consecutive dialysis sessions, and for a minimum of 3 weeks. Patients will wear two sensors (upper back and lower anterior leg). In Sub-investigation B, patients will use the device throughout their whole treatment period, and for most patients, this will correspond to 2-6 dialysis treatments over 3 to 10 days. Patients will wear four patches (upper back, lateral thorax, anterior thigh, and lower anterior leg). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06053710
Study type Interventional
Source Mode Sensors AS
Contact Sigve N Aas, PhD
Phone 004741499074
Email sigve.aas@modesensors.com
Status Recruiting
Phase N/A
Start date November 13, 2023
Completion date December 31, 2024

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