Healthy subject
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age: Patients aged 20 years of age or older - <80 years (healthy adult at the time of obtaining informed consent) (2) Patients from whom written informed consent can be directly obtained
Exclusion criteria
Exclusion criteria: (1) Patients with expected survival less than 3 years due to malignancies or other reasons (2) Patients using life-sustaining electrical medical devices, such as artificial heart-lung devices (3) Patients using affixed electrical medical devices, such as ECG recorders (4) Patients who are participating in another clinical trial for a pharmaceutical product or medical device (5) Patients with dementia that seriously disturbs activities of daily life (6) Females who wish to become pregnant or are presently pregnant or nursing mothers (if the patient is a woman of childbearing potential, a pregnancy test must be performed) and others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, adverse reactions which are related to or undeniable to study treatment, and their frequencies. | — |
Countries
Japan
Contacts
Japanese Organization for Medical Device Development, Inc. COO