Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor (DELOS)

Mode Sensors

Status: Enrolling

Conditions: Edema; Kidney Failure; Overhydration

Treatments: Device: Wearable bioimpedance sensor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06053710

CTR0042A DELOS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Patients with chronic kidney failure

Other group

Description:

Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.

Treatment:

Device: Wearable bioimpedance sensor

Patients with severe overhydration

Other group

Description:

Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, anterior thigh, and lower anterior leg throughout an intensive dialysis treatment regime (\~2-10 days).

Treatment:

Device: Wearable bioimpedance sensor