NCT04371081

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DEVICE	Amplatzer Piccolo Occluder	Interventional placement of vascular occluder

Timeline

• Start date: 2020-04-01
• Primary completion: 2025-09-10
• Completion: 2027-07-31
• First posted: 2020-05-01
• Last updated: 2025-10-03

Locations

1 site across 1 country: Japan