NCT03990818

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

June 17, 2019

Last Update Submit

September 20, 2019

Conditions

Dialysis Related ComplicationDehydration

Outcome Measures

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

    August - December 2019

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients for hemodialysis

You may qualify if:

  • Patients for hemodialysis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levanger Hospital

Levanger, Norway

RECRUITING

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Magnus Nordahl

    Mode Sensors AS

    STUDY CHAIR

Central Study Contacts

Jørn Kværness

CONTACT

+4795089723jorn@modesensors.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

August 20, 2019

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

NO(1)