Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection a Pilot Single-center Prospective Case-series Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
NOVA
Brief Summary:
The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting
Detailed Description:
Despite technological advancements the rate of anastomotic leak after left colon and rectal resection remains high In most cases these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes The device C-REX developed by CarpoNovum may help the anastomosis construction providing at the same time a system to monitor the anastomosis until complete healing This may lead to reduced anastomotic leak rate and severity This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting
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