UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031219 |
|---|---|
| Receipt number | R000034434 |
| Scientific Title | Reconstruction of pulmonary artery using alcohol treated autologous pericardium |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2018/02/09 11:30:35 |
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Basic information
Public title
Reconstruction of pulmonary artery using alcohol treated autologous pericardium
Acronym
Reconstruction of pulmonary artery using alcohol treated autologous pericardium
Scientific Title
Reconstruction of pulmonary artery using alcohol treated autologous pericardium
Scientific Title:Acronym
Reconstruction of pulmonary artery using alcohol treated autologous pericardium
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Cardiovascular surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the safety and effectiveness of alcohol treated autologous pericardium during the reconstruction of pulmonary artery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Properties of forming pulmonary artery
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
| Maneuver |
Interventions/Control_1
At the time of operation, pulmonary arterial reconstruction is performed using alcohol treated pericardium.
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with congenital heart disease who need pulmonary arterial reconstruction
Key exclusion criteria
Patients who judged to be inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MASAAKI YAMAGISHI |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pediatric Cardiovascular Surgery
Zip code
Address
465 Kajii-cho Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5752
myama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIYAZAKI TAKAKO |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pediatric Cardiovascular Surgery
Zip code
Address
465 Kajii-cho Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5752
Homepage URL
takako-m@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
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
| 2018 | Year | 02 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 13 | 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
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034434
