Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615583
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection
Sponsor:
None
Organization:
None
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:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVA
Brief Summary:
The goal of this pilot clinical trial is provide preminary evidence of the effectiveness of the C-REX device developed by CarpoNovum AB in preventing anastomotic leak and improving anastomosis healing after sigmoid or high rectal resection in patients with colon neoplasia The primary aim of the study is to evaluate the rate of anastomotic leak in patients receiving the study device within 90 days from the surgical procedure
Detailed Description:
Despite technological advancements the rate of anastomotic leak after left colon and high rectal resection remains high around 20 The device C-REX developed by CarpoNovum may help the anastomosis construction and promote its 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 This pilot study will collect preliminary data on the rate and severity of 90-day anastomotic leak in patients receiving the C-REX device
Study Oversight
Has Oversight DMC:
None
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?:
None