Trials / Completed
CompletedNCT02100683
Nit-Occlud PDA Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 184 (actual)
- Sponsor
- PFM Medical, Inc · Industry
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
Summary
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PDA Coil | The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm. |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2019-11-20
- Completion
- 2022-08-10
- First posted
- 2014-04-01
- Last updated
- 2022-10-04
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02100683. Inclusion in this directory is not an endorsement.