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RECRUITING
NCT06700174

Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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

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)