UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002400
Receipt No. R000002946
Scientific Title Measurements of lateral pressure using an airway catheter during bronchoscopy
Date of disclosure of the study information 2009/09/01
Last modified on 2019/09/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Measurements of lateral pressure using an airway catheter during bronchoscopy
Acronym Lateral pressure measurements of stenosis
Scientific Title Measurements of lateral pressure using an airway catheter during bronchoscopy
Scientific Title:Acronym Lateral pressure measurements of stenosis
Region
Japan

Condition
Condition Tracheobronchial stenosis
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the location of flow limiting segments and the outcomes of interventional pulmonology
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To identify the exact location of the flow limiting segment
Key secondary outcomes To assess quantitatively the degree of tracheobronchial stenosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 For patients with tracheobronchial stenosis.
Point-by-point Plat was measured simultaneously using an airway catheter at all three points during interventional bronchoscopy.
Interventions/Control_2 For control subjects.
Point-by-point Plat was measured simultaneously using an airway catheter at all three points during bronchoscopy.
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 Interventional bronchoscopy is performed in patients with tracheobronchial stenosis.
Key exclusion criteria Patients with sever pulmonary dysfunction
Patients with unilateral atelectasis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Nishine
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Diseases, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL 044-977-8111
Email h2nishine@marianna-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Nishine
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Diseases, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL 044-977-8111
Homepage URL
Email h2nishine@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
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 St. Marianna University School of Medicine, Division of Graduate Student Affairs and Research Promotion
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.ac.jp

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 09 Month 01 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 95
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 Completed
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
2007 Year 10 Month 01 Day
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 29 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002946

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.