UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000002946