Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

NCT06053710 | Recruiting

• 1 other identifier: CTR0042A DELOS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Overhydration; Kidney Failure; Edema

Keywords

Hydration

Outcome Measures

Primary Outcomes (1)

• 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

  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

  1-4 days

• The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration

  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

  2-10 days

• The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration

  2-10 days

• Safety of the investigational device

  Up to 4 weeks

Study Arms (2)

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.

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).

Device: Wearable bioimpedance sensor

Interventions

Wearable bioimpedance sensor DEVICE

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.

Patients with chronic kidney failure; Patients with severe overhydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mode Sensors AS: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Rikshospitalet, Oslo University Hospital

Oslo, Norway

RECRUITING

Ullevål sykehus, Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Water Intoxication; Renal Insufficiency; Edema

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigve N Aas, PhD

  Mode Sensors AS

  STUDY DIRECTOR

• Nanna von der Lippe, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Hege K Pihlstrøm, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigve N Aas, PhD

CONTACT

004741499074; sigve.aas@modesensors.com

Frida Bremnes, M.Sc.

CONTACT

frida.bremnes@modesensors.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: November 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)