UMIN ID: UMIN000050606
Registered date:17/03/2023
A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation
Basic Information
| Recruitment status | Recruiting |
|---|---|
| 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. Safety (bleeding-related) |
|---|---|
| Secondary Outcome | 1. Safety (other than bleeding-related) 2. Histological diagnostic yield 3. Procedure duration 4. Specimen size 5. Sampling success in terms of the freezing time 6. Biomarker test success rate |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Any serious, concomitant medical condition 2. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting 3. Prior enrolment in the trial 4. Patients for whom a therapeutic bronchoscope and a 1.1-mm cryoprobe were not used 5. Pregnancy 6. The inability to temporarily interrupt anticoagulant/antiplatelet agents 7. A bleeding tendency |
Related Information
| Primary Sponsor | National Hospital Organization Nagoya Medical Center |
|---|---|
| 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 |