UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015197 |
|---|---|
| Receipt number | 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 21:44:41 |
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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
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
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
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
sugimo-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017653
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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