Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
NCT06700174 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2024-11-21
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)
Conditions
- Atrial Septal Defect (ASD)
Sponsors & Collaborators
-
Lifetech Scientific (Shenzhen) Co., Ltd.
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-24
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
Countries
- Turkey (Türkiye)
Study Locations
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