Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058058) titled 'Pulmonary artery plasty using ethanol-treated autologous pericardium' on July 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Pulmonary atresia, pulmonary stenosis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Pulmonary artery plasty using ethanol-treated autologous pericardium
Eligibility:
Age-lower limit - 1
days-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 Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 20 Day
Anticipated trial start date - 2025 Year 07 Month 20 Day
Last follow-up date - 2030 Year 05 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066359
Disclaimer: Curated by HT Syndication.
