UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019435 |
|---|---|
| Receipt number | R000022481 |
| Scientific Title | Balloon-expandable bioabsorbable stents for airway diseases after lung transplantation |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2019/03/03 11:48:33 |
* 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
Balloon-expandable bioabsorbable stents for airway diseases after lung transplantation
Acronym
Balloon-expandable bioabsorbable stents for airway diseases after lung transplantation
Scientific Title
Balloon-expandable bioabsorbable stents for airway diseases after lung transplantation
Scientific Title:Acronym
Balloon-expandable bioabsorbable stents for airway diseases after lung transplantation
Region
| Japan |
Condition
Condition
Airway complications after lung transplantation
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of balloon-expandable bioabsorbable stents for airway diseases after lung transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful rate of balloon-expandable bioabsorbable stenting for airway diseases
Key secondary outcomes
Rate of adverse events
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 bioabsorbable 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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospital patients who have airway complications after lung transplantation.
2) Airway diseases confirmed by chest computed tomography or bronchoscopy.
3) Finished junior high school or older than 15 of age.
Key exclusion criteria
1) Indication for other surgical treatments.
2) Severe renal or liver injury.
3) WBC<2,000/mm3, Plt<30,000/mm3, or Hb<6.0g/dl.
4) Broncho-esophageal or broncho-vascular fistula.
5) Unable to undergo hospital treatment.
6) Contraindication for bronchoscopy.
7) Severe heart or mental diseases.
8) Other unsuitable factors for the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Oto |
Organization
Okayama University Hospital
Division name
Organ Transplant Center
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 | Takashi Ohki |
Organization
Graduate school of medicine dentistry and pharmaceutical sciences, Okayama University
Division name
Department of 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
Homepage URL
takashi.ohki@gmail.com
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 21 | 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
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022481
