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A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
Start Date
July 31, 2024
Primary Completion Date
April 30, 2025
Completion Date
August 31, 2025
Last Updated
July 1, 2024
30
ESTIMATED participants
C-REX
DEVICE
Lead Sponsor
Istituto Clinico Humanitas
Collaborators
NCT06662786
NCT06663319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05239741