UMIN ID: UMIN000050607
Registered date:17/03/2023
A prospective observational study on cryobiopsy employing an ultrathin cryoprobe, a therapeutic bronchoscope, and a rigid bronchoscope to assess endobronchial lesions
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Endotracheal or endobronchial lesions |
Date of first enrollment | 2023/03/23 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | 1. Specimen size |
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Secondary Outcome | 1. Safety (bleeding-related) 2. Histological diagnostic yield 3. Sampling success rate by the freezing time 4. Biomarker test success rate |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Any serious, concomitant medical condition 2. Prior enrolment in this trial 3. Patients in whom a therapeutic bronchoscope and a 1.1-mm ultrathin cryoprobe were not used 4. Pregnancy 5. An inability to temporarily interrupt anticoagulant/antiplatelet agents 6. A bleeding tendency |
Related Information
Primary Sponsor | National Hospital Organization Nagoya Medical Center |
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Secondary Sponsor | |
Source(s) of Monetary Support | Self funding |
Secondary ID(s) |
Contact
public contact | |
Name | Masahide Oki |
Address | 4-1-1 Sannomaru, Naka-ku, Nagoya, Japan Japan 460-0001 |
Telephone | 052-951-1111 |
masahideo@gmail.com | |
Affiliation | National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |
scientific contact | |
Name | Masahide Oki |
Address | 4-1-1 Sannomaru, Naka-ku, Nagoya, Japan Japan |
Telephone | 052-951-1111 |
masahideo@gmail.com | |
Affiliation | National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |