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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031219
Receipt No. 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

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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
Email 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
Email takako-m@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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