Unique ID issued by UMIN | UMIN000001776 |
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Receipt number | R000002138 |
Scientific Title | Phase II study of dedicated silicone stent placement on the carina between the bronchus to the right upper lobe and bronchus intermedius |
Date of disclosure of the study information | 2009/03/16 |
Last modified on | 2014/06/11 09:41:06 |
Phase II study of dedicated silicone stent placement on the carina between the bronchus to the right upper lobe and bronchus intermedius
Dedicated silicone stent placement on the right secondary carina
Phase II study of dedicated silicone stent placement on the carina between the bronchus to the right upper lobe and bronchus intermedius
Dedicated silicone stent placement on the right secondary carina
Japan |
Airway stenotic diseases
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the feasibility, efficacy, and safety of the novel silicone stent designed for treating the airway stenosis around the carina between the bronchus to the right upper lobe and bronchus intermedius (right secondary carina)
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Success rate of dedicated stent placement
Change of pulmonary function test results
Change of dyspnea index
Frequency of adverse effects
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with airway stenosis around the right secondary carina who need to undergo stent placement to maintain airway patency
2. 20 years and above
3. Obtain informed consent in writing
1. Patients expected to have no indications for stenting because of existing narrowing of peripheral airway including either segmental bronchi of right upper lobe, middle lobe or lower lobe
2. Use of other stents expected to be clearly more effective in patients
3. In addition, patients expected to encounter difficulties in this study
10
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
masahideo@aol.com
Nagoya Medical Center
None
Self funding
NO
2009 | Year | 03 | Month | 16 | Day |
Published
http://journal.publications.chestnet.org/article.aspx?articleid=1661166
The study stent could be mounted successfully on the primary right carina in all 10 patients. Five patients underwent stenting using only the new stent, and the other 5 underwent stenting with it on the primary right carina and a silicone Y-stent on the main carina. The dyspnea index improved in 8 of 10 patients, including one mechanically-ventilated. Early complications developed in 3 patients (temporary pneumonia in 2 and retention of secretions in 1), and late complications occurred in 2 patients (granuloma formation in 1 and hemoptysis in 1).
Completed
2009 | Year | 02 | Month | 13 | Day |
2009 | Year | 03 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
Observation of the feasibility, efficacy, and safety of the novel silicone stent designed for treating airway stenosis around the right secondary carina
2009 | Year | 03 | Month | 15 | Day |
2014 | Year | 06 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002138
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