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NOT YET RECRUITING
NCT06615583
NA

A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-01

Completion Date

2026-03-31

Last Updated

2024-09-26

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Surgical device

The C-REX device consists of an invasive surgical part, including two anastomotic rings, and surgical instruments for assisting the placement of the anastomotic ring to intestine. The rings are loosen from the inside of the intestinal wall and expelled with faeces per rectum once the anastomosis is healed in approximately ten days.

Locations (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy