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Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

NCT06053710 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-20

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Wearable bioimpedance sensor

The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid volume. It is designed as an adhesive patch with four integrated electrodes.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Mode Sensors AS

    lead INDUSTRY

Principal Investigators

  • Sigve N Aas, PhD · Mode Sensors AS

  • Nanna von der Lippe, PhD · Oslo University Hospital

  • Hege K Pihlstrøm, PhD · Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053710 on ClinicalTrials.gov