A Novel Adaptive Anastomotic Technique for Left-sided Col... | NCT06481605

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

NCT06481605

Sponsor

Istituto Clinico Humanitas

Status

Unknown status

Last Update Posted

Jul 1, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Colorectal Neoplasms

Interventions

C-REX

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2024Estimated

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Jun 25, 2024

First Submission Date that Met QC Criteria

Jun 25, 2024

First Posted Date

Jul 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2024

Last Update Posted Date

Jul 1, 2024Actual

Name	Class
Carponovum AB	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-REX	Experimental	Patients will receive the C-REX device during anastomosis construction	Device: C-REX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-REX	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological anastomotic leaks	Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm	90 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Severity of anastomotic leaks	Assess the severity of the anastomotic leaks, classifying the events according to the International Study Group of Rectal Cancer (ISGR) criteria in the C-REX arm	90 days after surgery
Positive leak tests

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annalisa Spinelli, PhD	Contact	02 8224 7776	0039	colorapp@humanitas.it
Stefano De Zanet, MS	Contact	02 8224 7776	0039	colorapp@humanitas.it

Overall Officials

Name	Affiliation	Role
Antonino Spinelli, MD, PhD	Humanitas Research Hospital IRCCS, Rozzano-Milan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Humanitas Research Hospital		Rozzano	MI	20089	Italy

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided