Trials / Unknown
UnknownNCT03853070
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Kaneka Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ED Coil / Electro-detach Generator v4 | The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil. |
Timeline
- Start date
- 2018-12-11
- Primary completion
- 2019-12-01
- Completion
- 2021-12-01
- First posted
- 2019-02-25
- Last updated
- 2019-02-25
Locations
3 sites across 2 countries: Belgium, Germany
Source: ClinicalTrials.gov record NCT03853070. Inclusion in this directory is not an endorsement.