Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
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- STATUS
- Recruiting
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- End date
- May 31, 2025
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- participants needed
- 70
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- sponsor
- Abbott Medical Devices
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.
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.
Details
| Condition | Congenital Heart Defect, Congenital Heart Disease, Patent ductus arteriosus, Congenital Heart Disease |
|---|---|
| Age | 100 years and younger |
| Treatment | Amplatzer Piccolo Occluder |
| Clinical Study Identifier | NCT04371081 |
| Sponsor | Abbott Medical Devices |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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