Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT00713661
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2008-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Sponsor:
Nycomed
Organization:
Study Overview
Official Title:
Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
Status:
COMPLETED
Status Verified Date:
2012-02
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:
None
Brief Summary:
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-007254-62 | EUDRACT_NUMBER | None | View |