UMIN-CTR Clinical Trial

Basic information
Public title	Balloon-expandable metallic stents for airway diseases
Acronym	Balloon-expandable metallic stents for airway diseases
Scientific Title	Balloon-expandable metallic stents for airway diseases
Scientific Title:Acronym	Balloon-expandable metallic stents for airway diseases
Region	Japan

Condition
Condition	Airway complications after lung transplantation and airway malignancies
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of balloon-expandable metallic stents for airway diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Successful rate of balloon-expandable metallic stenting for airway diseases
Key secondary outcomes

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Balloon-expandable metallic stenting
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Airway complications after lung transplantation or airway malignancies 2) Airway diseases confirmed by chest computed tomography or bronchoscopy 3) No indication for other surgical treatments 4) A) WBC>2,000/mm3 B) Plt>30,000/mm3 C) Hb>6.0g/dL 5) Hospital patients
Key exclusion criteria	1) Severe myelosuppression, renal injury or liver injury 2) Broncho-esophageal or broncho-vascular fistula 3) Contraindication for bronchoscopy 4) Severe heart diseases 5) Severe mental diseases 6) Other unsuitable factors for the study
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takahiro Oto
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7265
Email	oto@md.okayama-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Seiichiro Sugimoto
Organization	Okayama University Hospital
Division name	General Thoracic Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7265
Homepage URL
Email	sugimo-s@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
Organization
Division
Category of Funding Organization	Other
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	2014 Year 09 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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	Completed
Date of protocol fixation	2014 Year 09 Month 16 Day
Date of IRB	2014 Year 09 Month 16 Day
Anticipated trial start date	2014 Year 09 Month 17 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 17 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017653