Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Last updated: February 16, 2024
Sponsor: Mode Sensors AS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Disease

Low Blood Sodium (Hyponatremia)

Nephropathy

Treatment

Wearable bioimpedance sensor

Clinical Study ID

NCT06053710
CTR0042A DELOS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 ofother electrical medical equipment for which an interaction effect with theinvestigational 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 investigatorprecludes participation

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Wearable bioimpedance sensor
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
December 31, 2024

Study 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).

Connect with a study center

  • Rikshospitalet, Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Ullevål sykehus, Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

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