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Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor (DELOS)

Primary Purpose

Overhydration, Kidney Failure, Edema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearable bioimpedance sensor
Sponsored by
Mode Sensors AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overhydration focused on measuring Hydration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Patients with chronic kidney failure

    Patients with severe overhydration

    Arm Description

    Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.

    Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, and lower anterior leg throughout an intensive dialysis treatment regime (~2-10 days).

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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
    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
    Safety of the investigational device
    Frequency and severity of adverse device effects.

    Full Information

    First Posted
    September 19, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Mode Sensors AS
    Collaborators
    Oslo University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06053710
    Brief Title
    Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
    Acronym
    DELOS
    Official Title
    Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 6, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mode Sensors AS
    Collaborators
    Oslo University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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 three patches (upper back, lateral thorax, and lower anterior leg).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overhydration, Kidney Failure, Edema
    Keywords
    Hydration

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with chronic kidney failure
    Arm Type
    Other
    Arm Description
    Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.
    Arm Title
    Patients with severe overhydration
    Arm Type
    Other
    Arm Description
    Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, and lower anterior leg throughout an intensive dialysis treatment regime (~2-10 days).
    Intervention Type
    Device
    Intervention Name(s)
    Wearable bioimpedance sensor
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
    Description
    Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
    Time Frame
    1-4 days
    Secondary Outcome Measure Information:
    Title
    The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients
    Description
    Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
    Time Frame
    1-4 days
    Title
    The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration
    Description
    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
    Time Frame
    2-10 days
    Title
    The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration
    Description
    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
    Time Frame
    2-10 days
    Title
    The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration
    Description
    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
    Time Frame
    2-10 days
    Title
    Safety of the investigational device
    Description
    Frequency and severity of adverse device effects.
    Time Frame
    Up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sigve N Aas, PhD
    Phone
    004741499074
    Email
    sigve.aas@modesensors.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Frida Bremnes, M.Sc.
    Email
    frida.bremnes@modesensors.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sigve N Aas, PhD
    Organizational Affiliation
    Mode Sensors AS
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nanna von der Lippe, PhD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hege K Pihlstrøm, PhD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

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