Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058905) titled 'Investigation of blood flow dynamics in intra-articular tissues using indocyanine green fluorescence' on Sept. 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Knee joint disorders (ligament injury, meniscus tears, cartilage injury, synovitis, osteoarthritis, etc.) and shoulder joint disorders (rotator cuff tears, shoulder dislocation, etc.)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate intra-articular blood flow during knee and shoulder joint surgery using ICG fluorescence.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - During arthroscopic surgery, ICG is administered intravenously and blood flow is visualized using a specialized arthroscope.
Eligibility:
Age-lower limit - 12
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Individuals diagnosed with knee joint disorders such as ligament injuries, meniscus tears, cartilage injury, synovitis, osteoarthritis, or shoulder joint disorders such as rotator cuff tears or shoulder dislocation, and who are scheduled to undergo arthroscopic surgery.
Among the above patients, those who have provided written consent.
Among the above patients, those who were 12 years of age or older at the time of consent acquisition.
Includes individuals who have previously undergone knee or shoulder surgery.
Key exclusion criteria - Individuals with a history of hypersensitivity to ICG.
Individuals with a history of iodine hypersensitivity.
Other individuals deemed unsuitable by the principal investigator or co-investigator.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 26 Day
Anticipated trial start date - 2025 Year 10 Month 07 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067040
Disclaimer: Curated by HT Syndication.