Trials / Completed
CompletedNCT01479218
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Occlutech International AB · Industry
- Sex
- All
- Age
- 6 Months – 70 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Occlutech PDA occluder | Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-02-01
- Completion
- 2014-05-01
- First posted
- 2011-11-24
- Last updated
- 2024-02-15
Locations
2 sites across 2 countries: Malaysia, Vietnam
Source: ClinicalTrials.gov record NCT01479218. Inclusion in this directory is not an endorsement.