OverhydrationDELOSNCT06053710
Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
A study testing Wearable bioimpedance sensor in people with Overhydration and Kidney Failure, run by Mode Sensors AS at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overhydration, Kidney Failure, Edema
- What is being tested?
- Wearable bioimpedance sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesNorway
- Study dates
- 13 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Frida Bremnes, M.Sc. contact
Norway2 sites, 2 recruiting
- Recruiting
Rikshospitalet, Oslo University Hospital
Oslo
Hege K Pihlstrøm, PhD
- Recruiting
Ullevål sykehus, Oslo University Hospital
Oslo
Nanna von der Lippe, PhD
About this study
Official title: Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
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.
Read the detailed 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).
- Conditions
- Overhydration, Kidney Failure, Edema
- Being tested
- Wearable bioimpedance sensor
- Keywords
- Hydration
- Medical subject headings
- Water Intoxication, Renal Insufficiency, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable bioimpedance sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney failure | Other | Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks. Receives: Device: Wearable bioimpedance sensor |
| Patients with severe overhydration | Other | 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). Receives: Device: Wearable bioimpedance sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
Measured: 1-4 days
Secondary outcomes (6)
The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients
Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
Measured: 1-4 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Measured: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration
Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Measured: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration
Relative change in extracellular resistance of the lateral thorax, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Measured: 2-10 days
Safety of the investigational device
Frequency and severity of adverse device effects.
Measured: Up to 4 weeks
The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh
Relative change in extracellular resistance of the anterior thigh, measured by the bioimpedance device
Measured: 2-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start13 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverhydrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Sigve N Aas, PhD, Study director, Mode Sensors ASNanna von der Lippe, PhD, Principal investigator, Oslo University HospitalHege K Pihlstrøm, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053710
- Sponsor's protocol ID
- CTR0042A DELOS
- Acronym
- DELOS
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
- ClinicalTrials.gov ID
- NCT06053710
- Acronym / sponsor ID
- DELOS / CTR0042A DELOS
- Conditions
- Overhydration, Kidney Failure, Edema
- Keywords
- Hydration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Sep 2023 (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.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney failure | Other | Device: Wearable bioimpedance sensorPatients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks. |
| Patients with severe overhydration | Other | Device: Wearable bioimpedance sensorPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable bioimpedance sensorThe 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. | Device | Patients with chronic kidney failure, Patients with severe overhydration |
Primary outcome
The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
Time frame: 1-4 days
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
6 secondary outcomes
The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients
Time frame: 1-4 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration
Time frame: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration
Time frame: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration
Time frame: 2-10 days
Safety of the investigational device
Time frame: Up to 4 weeks
The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh
Time frame: 2-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Overhydration
Not yet recruiting
Performance Evaluation of Lucie™ for Hydration of Dialysis Patients
Diabetes
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.
Frida Bremnes, M.Sc. contact
Sigve N Aas, PhD study director
Mode Sensors AS
Nanna von der Lippe, PhD principal investigator
Oslo University Hospital
Hege K Pihlstrøm, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable bioimpedance sensor in people with Overhydration and Kidney Failure, run by Mode Sensors AS at 2 sites 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 3 inclusion and 6 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sigve N Aas, PhD (004741499074, sigve.aas@modesensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients (time frame: 1-4 days). 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 20 Feb 2024.