NCT06481605

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 25, 2024

Last Update Submit

June 25, 2024

Conditions

Colorectal Neoplasms

Keywords

Colorectal NeoplasmAnastomosisSurgical device

Outcome Measures

Primary Outcomes (1)

  • Radiological anastomotic leaks

    Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm

    90 days after surgery

Secondary Outcomes (9)

  • Severity of anastomotic leaks

    90 days after surgery

  • Positive leak tests

    Intraoperative

  • Positive C-REX integrity tests

    Intraoperative

  • Time of anastomosis construction

    Intraoperative

  • Anastomotic stenosis

    90 days after surgery

  • +4 more secondary outcomes

Study Arms (1)

C-REX

EXPERIMENTAL

Patients will receive the C-REX device during anastomosis construction

Device: C-REX

Interventions

C-REXDEVICE

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.

Also known as: C-REX RectoAid Cath device
C-REX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years old, men or women.
  • Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice.
  • Patient indicated to elective minimally invasive sigmoid or high rectal resection.

You may not qualify if:

  • Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
  • Patients with preoperative evidence of distal metastasis.
  • Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis.
  • Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
  • Patients indicated to defunctioning ileostomy (intention to treat).
  • Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Antonino Spinelli, MD, PhD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Spinelli, PhD

CONTACT

02 8224 7776colorapp@humanitas.it

Stefano De Zanet, MS

CONTACT

02 8224 7776colorapp@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot, single-center, interventional, prospective case-series study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

July 31, 2024

Primary Completion

April 30, 2025

Study Completion

August 31, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

IT(1)