Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-28 @ 4:32 PM
Study NCT ID:
NCT00671203
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Sponsor:
Spectros Corporation
Organization:
Study Overview
Official Title:
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Status:
COMPLETED
Status Verified Date:
2011-01
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:
Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable.
This purpose of this study is to establish how T-Stat can best be used to prevent deaths.
This purpose of this study is to establish how T-Stat can best be used to prevent deaths.
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 |
|---|---|---|---|---|
| NIH DK068927 | None | None | View |