Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Launched by MODE SENSORS AS · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new wearable device that can help detect fluid buildup in patients with kidney problems or those experiencing overhydration. The device measures how much fluid is in the body, which is important for people on regular dialysis treatments. There are two groups of patients being monitored: one group has stable chronic kidney disease and is receiving regular hemodialysis, while the other group is undergoing more intensive dialysis due to severe fluid overload.

To participate in this study, you need to be at least 18 years old and regularly undergoing hemodialysis. If you have severe overhydration, you may be scheduled for intensive dialysis treatments. However, there are some exclusions, such as having certain medical devices like pacemakers or being pregnant. Participants will wear the bioimpedance sensor during their treatment sessions and help researchers understand how well this device can track fluid levels in the body. It’s a chance to contribute to important research that could improve care for patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A)
• • Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B)
• Exclusion Criteria:
• • Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
• • Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
• • Patients undergoing MRI
• • Breached skin at patch mounting area
• • Pregnancy
• • Any medical or psychiatric condition, which in the opinion of the investigator precludes participation