Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059295) titled 'Prospective study on the safety and efficacy of cryobiopsy through a cuffed long tracheal tube' on Oct. 6.

Study Type: Observational

Primary Sponsor: Institute - National Hospital Organization Nagoya Medical Center

Condition: Condition - Peripheral pulmonary lesions suspected of malignancy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and efficacy of cryobiopsy using a cuffed long tracheal tube in the assessment of peripheral pulmonary lesions Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients undergoing cryobiopsy with a cuffed long tracheal tube for assessment of peripheral pulmonary lesions 2. 20 years old or more 3. Provision of written informed consent Key exclusion criteria - 1. Lesions with a leading bronchus inaccessible to the long tracheal tube (e.g., right apical lung lesions, left upper lobe lesions) 2. Patients in whom a long tracheal tube is not used 3. Prior enrollment in the trial 4. Any serious concomitant medical condition 5. Lesions located within one-third of the hilar ellipse on chest computed tomography 6. Requirement for a bronchoscopic procedure to explore a non-target lesion in the same session 7. Lesions adjacent to a large vessel 8. Distance of < 10 mm between the visceral pleura and the central margin of the lesion 9. Pregnancy 10. Inability to temporarily discontinue anticoagulant/antiplatelet therapy 11. Bleeding tendency Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 09 Month 04 Day Anticipated trial start date - 2025 Year 10 Month 06 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067824

Disclaimer: Curated by HT Syndication.