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

NCT06481605 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Carponovum AB

    collaborator INDUSTRY

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Antonino Spinelli, MD, PhD · Humanitas Research Hospital IRCCS, Rozzano-Milan

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-04-30
Completion
2025-08-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481605 on ClinicalTrials.gov