Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058437) titled 'Evaluation of the Usefulness of Intraoral Pressure Measurement Using IOP-01 for Respiratory Muscle Strength Assessment Before and After Pulmonary Resection' on July 14.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - primary lung cancer, metastatic lung nodules
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To quantitatively evaluate changes in respiratory muscle strength before and after pulmonary resection using the IOP-01 device (Kobata Gauge MFG Co., Ltd.), and to clarify its validity and clinical usefulness.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients scheduled to undergo pulmonary resection for primary lung cancer (or suspected cases) or metastatic lung tumors (or suspected cases)
Patients aged 20 years or older at the time of consent
Patients who have provided written informed consent to participate in the study
Key exclusion criteria - Patients deemed inappropriate for participation by the principal investigator or co-investigators
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 05 Month 10 Day
Date of IRB - 2025 Year 06 Month 11 Day
Anticipated trial start date - 2025 Year 07 Month 14 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066819
Disclaimer: Curated by HT Syndication.
