Dialysis Related ComplicationDELAGENCT03990818
Continuous Registration of Bioimpedance During Hemodialysis
An observational study of Dialysis Related Complication and Dehydration, run by Mode Sensors AS at 1 site in Norway.
Trial summary
This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dialysis Related Complication, Dehydration
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 20 Aug 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for hemodialysis
Who may be able to join
- Patients for hemodialysis
Who cannot join
- Acute in-current disease.
- Known adverse reaction to medical adhesive
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Levanger Hospital
Levanger
Carl Platou, carl.platou@helse-nordtrondelag.no
Solfrid Romundstad
About this study
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.
- Conditions
- Dialysis Related Complication, Dehydration
- Medical subject headings
- Dehydration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of patch performance
Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results
Measured: August - December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Aug 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Magnus Nordahl, Study chair, Mode Sensors AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990818
- Sponsor's protocol ID
- 2019 DELAGE
- Acronym
- DELAGE
- Status last verified
- Sep 2019
- First submitted
- 17 Jun 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Registration of Bioimpedance During Hemodialysis
- ClinicalTrials.gov ID
- NCT03990818
- Acronym / sponsor ID
- DELAGE / 2019 DELAGE
- Conditions
- Dialysis Related Complication, Dehydration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for hemodialysis
Key inclusion criteria (1 listed)
- Patients for hemodialysis
Key exclusion criteria (2 listed)
- Acute in-current disease.
- Known adverse reaction to medical adhesive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of patch performance
Time frame: August - December 2019
Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Nordahl study chair
Mode Sensors AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis Related Complication and Dehydration, run by Mode Sensors AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jørn Kværness (+4795089723, jorn@modesensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of patch performance (time frame: August - December 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.