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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001776
Receipt No. 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

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Basic information
Public title Phase II study of dedicated silicone stent placement on the carina between the bronchus to the right upper lobe and bronchus intermedius
Acronym Dedicated silicone stent placement on the right secondary carina
Scientific Title Phase II study of dedicated silicone stent placement on the carina between the bronchus to the right upper lobe and bronchus intermedius
Scientific Title:Acronym Dedicated silicone stent placement on the right secondary carina
Region
Japan

Condition
Condition Airway stenotic diseases
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Success rate of dedicated stent placement
Key secondary outcomes Change of pulmonary function test results
Change of dyspnea index
Frequency of adverse effects

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Oki
Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL 052-951-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahide Oki
Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL 052-951-1111
Homepage URL
Email masahideo@aol.com

Sponsor
Institute Nagoya Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journal.publications.chestnet.org/article.aspx?articleid=1661166
Number of participants that the trial has enrolled
Results
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of the feasibility, efficacy, and safety of the novel silicone stent designed for treating airway stenosis around the right secondary carina

Management information
Registered date
2009 Year 03 Month 15 Day
Last modified on
2014 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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