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Study device evaluation study

Study device evaluation study - Study device evaluation study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057109
Enrollment
6
Registered
2025-02-21
Start date
2025-02-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Measurement A: Wear Measurement Device under developing for up to 3 hours Measurement B:Wear Measurement Device under developing for up to 2 hours x 3 times x 2 days

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy Japanese men and women between the ages of 20 and 60 at the time of consent. 2)Participants who have been fully informed of the purpose and content of the study, and submit the written informed consent form. 3)Participants who can report their own urge to urinate. 4)Participants who can comply with the restrictions from the day before the study.

Exclusion criteria

Exclusion criteria: 1)Participants who currently suffer from or have a history of serious heart disease, pulmonary disease, digestive system disease (esophagus, stomach, small intestine, large intestine, liver, pancreas, etc.), high blood pressure, diabetes, malignant tumors, etc. 2)Participants who are currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases. 3)Participants with a medical history related to urination who are currently receiving treatment. 4)Participants who are aware of frequent urination. 5)Participants who cannot drink 500 mL of water within 15 minutes. 6)Participants who regularly use medications, quasi-drugs, or health foods (such as foods for specified health uses, foods with nutrient function claims, foods with functional claims, supplements, etc.) that may affect the various tests conducted within this study. 7)Participants who are currently receiving treatment at a medical institution for diseases that may affect the various tests conducted within this study. 8)Participants who have or may have metallic foreign objects in or on the surface of their abdomen. 9)Participants who are participating in a clinical study or have participated in another clinical study within 1 month from the date of obtaining consent. 10)Participants who plan to participate in another clinical study during the study period. 11)Participants who may develop skin irritation from contact with medical tape or similar materials. 12)Participants who judged as unsuitable for this study by the principal investigator for any reasons.

Design outcomes

Primary

MeasureTime frame
Comparison of data obtained from the currently developing Device (study device) and Ultrasound Echo

Countries

Japan

Contacts

Public ContactMasako Mizuuchi

APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.

food-contact@apoplus.co.jp03-6777-7789

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026