Trials / Unknown
UnknownNCT04218292
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan
Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- KA Medical, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Micro Plug Set | The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature. |
Timeline
- Start date
- 2020-03-31
- Primary completion
- 2022-02-28
- Completion
- 2022-02-28
- First posted
- 2020-01-06
- Last updated
- 2021-04-23
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04218292. Inclusion in this directory is not an endorsement.