Detecting fluid accumulation using a wearable sensor
Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
This study is testing a wearable sensor to see if it can help people with kidney issues detect fluid build-up during their dialysis treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mode Sensors AS Industry-sponsored |
| Locations | 2 sites (Oslo and 1 other locations) |
| Trial ID | NCT06053710 on ClinicalTrials.gov |
What this trial studies
This investigation is a prospective cohort study that monitors two groups of patients using a wearable bioimpedance sensor during their scheduled hemodialysis treatments. The study aims to evaluate the sensor's effectiveness in detecting both local and systemic fluid accumulation. In one group, patients with stable chronic kidney disease will be observed over multiple dialysis sessions, while the other group will focus on patients undergoing intensive dialysis due to severe overhydration. The device will be worn at various locations on the body to track hydration status throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing regular hemodialysis or scheduled for intensive dialysis due to severe overhydration.
Not a fit: Patients with known allergies to the sensor materials, those with implantable medical devices, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of fluid status in patients with kidney issues, potentially enhancing treatment outcomes.
How similar studies have performed: While the use of wearable bioimpedance sensors is a growing field, this specific application in monitoring fluid accumulation during dialysis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo and 1 other locations
- Rikshospitalet, Oslo University Hospital — Oslo, Norway (Recruiting)
- Ullevål sykehus, Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Nanna von der Lippe, PhD — Oslo University Hospital
- Study coordinator: Sigve N Aas, PhD
- Email: sigve.aas@modesensors.com
- Phone: 004741499074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.