Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183086
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-10-19
Brief Title:
PMCF Study on the Safety of Linovera for the Treatment of Category-I Pressure UlcersInjuries
Sponsor:
B Braun Medical SA
Organization:
B Braun Medical SA
Study Overview
Official Title:
Prospective Multicentre Single-arm Controlled Study on the Safety of Linovera for the Treatment of Category-I Pressure UlcersInjuries
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRELINOIL
Brief Summary:
To assess the safety and performance of Linovera in the treatment of Category- I pressure ulcersinjuries
Detailed Description:
The aim of this clinical study is to generate further clinical evidence for the use and benefit of Linovera in the treatment of Category-I PUs The results of this study will generate further clinical evidence for the use and the benefit of Linovera in this indication
Furthermore the proactive collection of clinical data for Linovera will support the maintenance of this skin oil on the market so that in the future other patients can receive the product for the treatment of Category-I PUs
Furthermore the proactive collection of clinical data for Linovera will support the maintenance of this skin oil on the market so that in the future other patients can receive the product for the treatment of Category-I PUs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None