Status:
COMPLETED
Contributing Factors to Local Bioimpedance Spectroscopy
Lead Sponsor:
Mode Sensors AS
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Fluid and Electrolyte Imbalance
Overhydration
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This is an exploratory interventional study. The aim of the investigation is to identify and quantify contributing factors to local bioimpedance spectroscopy (BIS) measured by a wearable sensor patch,...
Detailed Description
The investigational devices (patches) will perform near-continuous measurements of multifrequency bioimpedance (BIS), temperature, and body orientation (accelerometer) during the entire period of wear...
Eligibility Criteria
Inclusion
- 18 to 50 years of age, at the time of signing the informed consent
- Overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound.
- Use of adequate birth control for women of childbearing potential. Inclusion is possible when an acceptable effective contraceptive measure is used (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
- Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
- Breached skin at patch mounting area.
- 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.
- Planned magnetic resonance (MR) imaging during the investigation period
- Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
- Pregnancy
- Breastfeeding
- History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
- Any known cardiac disease that, at the investigator's discretion, warrants exclusion from the study, including but not limited to cardiac arrhythmia, esophageal varices, and aneurysms.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06003205
Start Date
September 4 2023
End Date
September 14 2023
Last Update
March 12 2024
Active Locations (1)
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1
Physiology lab. Aker hospital, Oslo University Hospital
Oslo, Norway, 0586