Tokyo, June 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061856) titled 'Safety and Efficacy of Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease' on June 10.

Study Type: Observational

Primary Sponsor: Institute - Department of Clinical Research, National Hospital Organization Okayama Medical Center, Okayama, Japan

Condition: Condition - interstitial lung disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and diagnostic utility of ultrathin cryobiopsy using a 1.1-mm cryoprobe with a direct specimen retrieval technique through the therapeutic bronchoscope working channel for bronchoscopic diagnosis of ILD. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old =20 years. Written informed consent for participation in this study obtained from the patient. Key exclusion criteria - Patients strongly suspected of having lung cancer based on elevated tumor markers in blood tests or imaging findings. Lesions located in the inner one-third of the lung field from the hilum. Patients who require additional bronchoscopic procedures other than bronchoalveolar lavage and cryobiopsy before the examination. Lesions adjacent to major blood vessels. Lesions in which the distance from the planned cryobiopsy site to the pleura is less than 1 cm. Pregnant women or women who may be pregnant. Patients receiving anticoagulant or antiplatelet therapy who cannot discontinue these medications prior to the procedure. Patients with a marked bleeding tendency. Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 01 Day Date of IRB - 2026 Year 06 Month 09 Day Anticipated trial start date - 2026 Year 06 Month 10 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=R000069964

Disclaimer: Curated by HT Syndication.