NCT06481605

A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection

A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	C-REX	The C-REX is a CE-marked class IIa device consisting of an invasive surgical part, including two anastomotic rings, intended for short-term use, and surgical instruments LapAid and RectoAid for assisting the placement of the anastomotic ring to intestine. The device is supplemented with a catheter to monitor the anastomosis.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-04-30
• Completion: 2025-08-31
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: Italy