UMIN ID: UMIN000000508
Registered date:01/11/2006
A phase II study of using a thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Benign or malignant pulmonary lesions |
| Date of first enrollment | 2005/03/01 |
| Target sample size | 170 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Diagnostic yield |
|---|---|
| Secondary Outcome | 1. Frequency of adverse effects 2. Level of bronchus reached; comparison with standard bronchoscope 3. Optimal number of biopsies |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Serious concomitant medical illness 2. Obvious central pulmonary lesion 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Obvious bleeding tendency 6. Pregnancy 7. Other clinical difficulties in this study |
Related Information
| Primary Sponsor | Nagoya Medical Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahide Oki |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan Japan |
| Telephone | 052-951-1111 |
| Affiliation | Nagoya Medical Center Department of Respiratory Medicine |
| scientific contact | |
| Name | Masahide Oki |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan Japan |
| Telephone | |
| Affiliation | Nagoya Medical Center Department of Respiratory Medicine |