NCT03404934

Clinical Study Verifying C-REX LapAid in Clinical Practice

Terminated NA Last updated 30 April 2020

What this trial tests

NA trial testing C-REX Ring-locking Procedure in Cancer Colonic in 13 participants. Terminated before completion.

Timeline

3 January 2018

Primary endpoint
30 April 2019

10 May 2019

Quick facts

Lead sponsor	Carponovum AB
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	3 January 2018
Primary completion	30 April 2019
Estimated completion	10 May 2019
Sites	1 location across China

Drugs / interventions tested

• C-REX Ring-locking Procedure

Conditions studied

• Cancer Colonic — all drugs for Cancer Colonic →

Sponsor

Carponovum AB

Who can join

Adults 18 to 80, any sex, with Cancer Colonic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further.

The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively.

Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters.

The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful preclinical study encourages a clinical verification in patients undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking Procedure by use of C-REX LapAid and C-REX DMH/DMHC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.