Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059340) titled 'Portable Conebeam CT Guided Bronchoscopy for Peripheral Pulmonary Lesions: A Pilot Study' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Shimane University Hospital
Condition:
Condition - peripheral pulmonary lesions
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To verify the feasibility of radial EBUS bronchoscopy combined with portable cone-beam CT.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - During radial endobronchial ultrasound (EBUS) bronchoscopy for peripheral pulmonary lesions, a portable cone-beam CT system (mobile C-arm, Cios Spin; Siemens Healthcare) is used to confirm the position of the lesion and biopsy tool. One scan is performed, lasting approximately 30 seconds. Reconstructed images are reviewed immediately, and bronchoscopy is then continued as usual.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Adult patients (20 years old or older) scheduled to undergo bronchoscopy at Shimane University Hospital
Patients with a peripheral pulmonary lesion on imaging for which radial endobronchial ultrasound (EBUS) guided biopsy is clinically indicated
Patients who have received a full explanation of the study and provided written informed consent
Key exclusion criteria - Patients deemed inappropriate for participation due to radiation exposure considerations
Patients judged by the attending physician or bronchoscopist to be unsuitable for inclusion in this study
Patients found to be ineligible after consent has been obtained
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 06 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067865
Disclaimer: Curated by HT Syndication.