UMIN ID: UMIN000001310
Registered date:11/08/2008
An open-label prospective trial designed to evaluate the safety and efficacy of bronchoscopic lung volume reduction (BLVR) by autologous blood injection in emphysematous lung diseases
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Emphysematous lung disease |
| Date of first enrollment | 2008/08/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Transbronchial autologous blood injection |
Outcome(s)
| Primary Outcome | Incidence of adverse events/ Changes of symptomatic relief assessed by dyspnea scale/ Changes of pulmonary physiological parameters |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Evidence of active infection. 2) Evidence of systemic diseases or neoplasia expected to compromise survival during 5-yr period. 3) Any disease or condition that interferes with completion of initial or follow-up assessments. 4) Patients who are judged by the principal or other investigators to be not eligible for enrollment in the study. |
Related Information
| Primary Sponsor | NDMC COPD Research Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | National Defense Medical College Division of Respiratory Medicine, Department of Medicine |
| scientific contact | |
| Name | Hideo Kobayashi |
| Address | 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan Japan |
| Telephone | |
| Affiliation | National Defense Medical College Division of Respiratory Medicine, Department of Medicine |