Clinical Trial Verifying C-REX LapAid and C-REX DMH/DMHC

NCT03179358 | Completed

• 1 other identifier: CREX-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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 (C-reactive protein)-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 quality of life 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 Colon; Polyp of Colon

Outcome Measures

Primary Outcomes (1)

• Time to evacuation of the short-term implant

  The subject informs the clinical investigator and hand over the expelled short-term implant

  About 2 weeks after surgery

Secondary Outcomes (7)

• Time to first intestinal sounds

  Up to 30 days after surgery

• Time to first passage of gas

  Up to 30 days after surgery

• Time to first defecation

  Up to 30 days after surgery

• Number of postoperative interventions related to the device

  Up to 30 days after surgery

• Integrity pressure

  The operation day

Other Outcomes (4)

• Hemoglobin

  Up to 30 days after surgery, when needed

• WBC (white blood cell)

  Up to 30 days after surgery, when needed

• Physical examination

  Up to 30 days after surgery

Study Arms (1)

C-REX group

EXPERIMENTAL

After resection of the disease in colon, the intestinal ends will be anastomosed by the investigational device, i.e. C-REX LapAid and C-REX DMH/DMHC included in the C-REX Ring-locking Procedure.

Device: C-REX Ring-locking Procedure

Interventions

C-REX Ring-locking Procedure DEVICE

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

C-REX group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥ 18 years and ≤ 70 years.
• Planned resection due to benign or malign disease in the left colon (descending colon and sigmoid) or the upper rectum (15 cm above the anal rim).
• Cognitive ability to take part in the study and understand the information he/she receives about participating in the study.
• Sign the informed consent form.

You may not qualify if:

• Urgent medical condition requiring immediate care.
• Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or dissemination (metastases) of cancer.
• Stenosis or other obstructions in the anal passage.
• Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis.
• Health condition classified as ASA (American Society of Anesthesiologists) score III - VI.
• Albumin level less than 35 g/l.
• Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease).
• Disease that requires more than one anastomosis during the surgical procedure.
• Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery.
• Contraindications to general anesthesia.
• Perioperative detection of extreme variants of intestinal diameters or wall thickness.
• Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study.
• BMI \> 35.
• Heart attack ≤ 6 months or sever heart disease.
• Severe embolic disease.

Sponsors & Collaborators

• Carponovum AB: lead
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Qi Luo

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 7, 2017
• Study Start: September 29, 2016
• Primary Completion: June 10, 2017
• Study Completion: June 10, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)