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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003391
Receipt No. R000003698
Scientific Title Impulse oscillometry in Interventional bronchoscopy
Date of disclosure of the study information 2010/03/28
Last modified on 2016/03/28

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Basic information
Public title Impulse oscillometry in Interventional bronchoscopy
Acronym Impulse oscillometry in Interventional bronchoscopy
Scientific Title Impulse oscillometry in Interventional bronchoscopy
Scientific Title:Acronym Impulse oscillometry in Interventional bronchoscopy
Region
Japan

Condition
Condition patients with central airway stensis
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm IOS is useful for the therapy evaluation before and after interventional bronchoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of IOS including R5, R20, X5, X20 and Fres before and after interventional bronchoscopy
Key secondary outcomes correlation between IOS and spirometry, cross sectional area at the narrowest segment using CT and NEP.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 IOS: to perform 2 times before and after therapy and 2 times during interventional bronchoscopy.
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
19 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with central airway stentosis
Key exclusion criteria one-lunged patients
not to get informed consent with patients e.g. dementia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Mineshita
Organization St. Marianna university school of medicine
Division name Division of Respiratory and Infectious diseases, department of internal medicine
Zip code
Address 2-16-1 Sugao Miyamae-ku, Kawasaki Kanagawa
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Handa
Organization St. Marianna university school of medicine
Division name Division of Respiratory and Infectious diseases, department of internal medicine
Zip code
Address 2-16-1 Sugao Miyamae-ku, Kawasaki Kanagawa
TEL 044-977-8111
Homepage URL
Email hiroshihstv@marianna-u.ac.jp

Sponsor
Institute St. Marianna university school of medicine
Division of Respiratory and Infectious diseases, department of internal medicine
Institute
Department

Funding Source
Organization St. Marianna university school of medicine
Division of Respiratory and Infectious diseases, department of internal medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 聖マリアンナ医科大学病院(神奈川)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Interventional procedures were successfully performed in all subjects. After interventional bronchoscopy, Rrs at all frequencies significantly decreased for TS (p value under 0.01). However, Rrs at all frequencies showed no significant decrease for subjects with UMBS. 
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
2010 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 28 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003698

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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