Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Patent Ductus Arteriosus Clinical Trial

Official title: Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Status Recruiting

Clinical Trial Summary

The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.

Clinical Trial Description

The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL. ;

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

• NCT number: NCT04371081
• Study type: Observational [Patient Registry]
• Source: Abbott Medical Devices
• Contact: Yuri Masui
• Phone: +81-3-3524-1792
• Email: yuri.masui@abbott.com
• Status: Recruiting
• Start date: April 1, 2020
• Completion date: May 31, 2025