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Recruitment status Completed
Unique ID issued by UMIN UMIN000015197
Receipt No. R000017653
Scientific Title Balloon-expandable metallic stents for airway diseases
Date of disclosure of the study information 2014/09/17
Last modified on 2019/03/22

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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/ctr_e/ctr_view.cgi?recptno=R000017653


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