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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009774
Receipt No. R000011447
Scientific Title Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula
Date of disclosure of the study information 2013/01/14
Last modified on 2015/10/02

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Basic information
Public title Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula
Acronym Bronchial occlusion in intractable pneumothorax
Scientific Title Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula
Scientific Title:Acronym Bronchial occlusion in intractable pneumothorax
Region
Japan

Condition
Condition Pneumothorax or bronchopleural fistula.
Classification by specialty
Pneumology Chest surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effectiveness of the silicone bronchial blocker - Endobronchial Watanabe Spigot (EWS) TM - compared with fibrin glue for treatment of intractable pneumothorax or bronchopleural fistula.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether air leaks are resolved. Whether air leaks are reduced. Amount of time to resolution or reduction of air-leaks.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Interventions. Bronchial occlusion with the silicone bronchial blockers -EWS TM-.
Interventions/Control_2 Control. Bronchial occlusion with fibrin glue.
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 Patients with pneumothorax or bronchopleural fistula who have persistent air leaks for 3 days or longer.
Key exclusion criteria Patients with uncontrolled infectious diseases. Patients with severe respiratory failure requiring 6 liters per min or 60% of oxygen supplementation to keep oxygen saturation above 90% measured by pulse oximeters. Pregnant women.

Patients who cannot tolerate tracheal intubation or bronchoscopy. Uncooperative patients.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Murata
Organization Tokyo Metropolitan Tama Medical Center
Division name Respiratory medicine
Zip code
Address 2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Murata
Organization Tokyo Metropolitan Tama Medical Center
Division name Respiratory Medicine
Zip code
Address
TEL 042-323-5111
Homepage URL
Email kengo_murata@tmhp.jp

Sponsor
Institute Respiratory Medicine, Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Goverment
Organization
Division
Category of Funding Organization Local Government
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
2013 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ers-education.org/events/international-congress/amsterdam-2015.aspx?idParent=144696
Number of participants that the trial has enrolled
Results
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 Main results already published
Date of protocol fixation
2009 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 02 Month 05 Day
Date trial data considered complete
2015 Year 02 Month 05 Day
Date analysis concluded
2015 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 13 Day
Last modified on
2015 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011447

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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