Trials / Completed
CompletedNCT04953949
IEIK13 For Neurosurgery
First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- 3-D Matrix Europe SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NU-MAX® | Topical Hemostat |
Timeline
- Start date
- 2021-08-06
- Primary completion
- 2023-08-04
- Completion
- 2023-11-04
- First posted
- 2021-07-08
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04953949. Inclusion in this directory is not an endorsement.