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Status unknownNCT03990818DELAGEUpdated Sep 23, 2019

Continuous Registration of Bioimpedance During Hemodialysis

An observational study in Dialysis Related Complication and Dehydration, sponsored by Mode Sensors AS. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by Mode Sensors AS · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 99 Years
Sex
All
01

Study summary

This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.

Read the detailed description

The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.

The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.

After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.

02

Conditions studied

  • Dialysis Related Complication
  • Dehydration

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03

In context

Dehydration

204 studies on the registry are indexed under Dehydration; 29 are open to participants now.

This study's planned enrollment of 25 is below the median of 101 across 48 observational studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

Mode Sensors AS is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients for hemodialysis

Inclusion criteria

  • Patients for hemodialysis

Exclusion criteria

Exclusion Criteria:

  • Acute in-current disease.
  • Known adverse reaction to medical adhesive
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of patch performance

    Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results

    Time frame: August - December 2019

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03990818
Lead sponsor
Mode Sensors AS
Collaborators
Helse Nord-Trøndelag HF
Responsible party
Sponsor
First posted
Jun 19, 2019
Start date
Aug 20, 2019
Primary completion
Sep 30, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Sep 23, 2019

Study contacts

Jørn Kværness
Contact
jorn@modesensors.com
+4795089723
Magnus Nordahl
study chair · Mode Sensors AS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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