UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058058 |
|---|---|
| Receipt number | R000066359 |
| Scientific Title | Pulmonary artery plasty using ethanol-treated autologous pericardium |
| Date of disclosure of the study information | 2025/07/20 |
| Last modified on | 2025/06/02 21:20:58 |
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Basic information
Public title
Pulmonary artery plasty using ethanol-treated autologous pericardium
Acronym
Pulmonary artery plasty using ethanol-treated autologous pericardium
Scientific Title
Pulmonary artery plasty using ethanol-treated autologous pericardium
Scientific Title:Acronym
Pulmonary artery plasty using ethanol-treated autologous pericardium
Region
| Japan |
Condition
Condition
Pulmonary atresia, pulmonary stenosis
Classification by specialty
| Cardiovascular surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the safety and efficacy on pediatric pulmonary artery plasty using ethanol-treated autologous pericardium in patients with various congenital heart disease and pulmonary artery stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of repaired pulmonary artery
Key secondary outcomes
Growing of repaired pulmonary artery
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
Pulmonary artery plasty using ethanol-treated autologous 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
| 1 | days-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who need pulmonary artery plasty associated with congenital heart disease
Key exclusion criteria
Patients having an allergic reaction to ethanol
Patients who seem inappropriate for pulmonary artery plasty using ethanol-treated autologous pericardium
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Koizumi |
Organization
Iwate Medical University
Division name
Department of Cardiovascular Surgery
Zip code
0283695
Address
2-1-1, Idaidori, Yahabacho, Shiwagun, Iwate
TEL
+81-19-613-7111
jkoizumi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Koizumi |
Organization
Iwate Medical University
Division name
Department of Cardiovascular Surgery
Zip code
0283695
Address
2-1-1, Idaidori, Yahabacho, Shiwagun, Iwate
TEL
+81-19-613-7111
Homepage URL
jkoizumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
Iwate Medical University
Address
2-1-1, Idaidori, Yahabacho, Shiwagun, Iwate
Tel
+81-19-613-7111
kenkyu-rinri@j.iwate-med.ac.jp
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
岩手医科大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 20 | 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
| 2025 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 05 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066359
