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Clinical Study Verifying C-REX LapAid in Clinical Practice

NCT03404934 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Colonic

Interventions

DEVICE

C-REX Ring-locking Procedure

The C-REX Ring-locking Procedure is a method based on adaptive anastomosis, in which intestinal ends adapt to each other after resection due to tumor, injury, or other disease. The investigational devices comprised of two components, i.e. C-REX LapAid and C-REX DMH/DMHC

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Carponovum AB

    lead INDUSTRY

Principal Investigators

  • Sanjun Cai, MD, PhD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2019-04-30
Completion
2019-05-10

Countries

  • China

Study Locations

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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 NCT03404934 on ClinicalTrials.gov