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Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Summary
The objective of this PMCF study is to: * confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)
Official title: A Multicenter, Prospective, Single-arm, Observational Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-09-24
Completion Date
2025-03-31
Last Updated
2024-11-21
Healthy Volunteers
No
Conditions
Locations (5)
Ankara (Bilkent) City Hospital
Ankara, Turkey (Türkiye)
Gazi Yasargil Woman and Child Hospital
Diyarbakır, Turkey (Türkiye)
Gaziantep University Hospital
Gaziantep, Turkey (Türkiye)
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)