Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060256) titled 'A study evaluating the measurement accuracy of bladder ultrasound devices in individuals with high BMI' on Jan. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Nihon University School of Medicine
Condition:
Condition - Healthy adults with high body mass index
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the accuracy of bladder volume measurements obtained using a portable ultrasound device in individuals with high BMI, in comparison with an established ultrasound-based reference method.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Measurement of bladder volume using a portable bladder ultrasound device and a portable/tablet type general ultrasound device
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - University sumo club members aged 18 years or older
Body mass index more than 30
Provided written informed consent
Key exclusion criteria - Participants who expressed refusal to participate in this study.
Participants who were judged by a physician to have hypertension, diabetes mellitus, heart disease, or other medical conditions requiring treatment.
Participants in whom serious health problems were identified prior to the start of the study.
Target Size - 37
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 08 Month 05 Day
Date of IRB - 2025 Year 10 Month 21 Day
Anticipated trial start date - 2025 Year 12 Month 21 Day
Last follow-up date - 2025 Year 12 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068773
Disclaimer: Curated by HT Syndication.
