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Clinical Study Verifying C-REX LapAid in Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404934
Recruitment Status : Terminated (Terminated by mutual agreement between the site and sponsor)
First Posted : January 19, 2018
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Carponovum AB

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. 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.


Condition or disease Intervention/treatment Phase
Cancer Colonic Device: C-REX Ring-locking Procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Non-randomized Controlled Study (NRS) Evaluating the Use of Adaptive Anastomosis (CREX) in Clinical Practise
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 10, 2019

Arm Intervention/treatment
Experimental: C-REX group
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

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





Primary Outcome Measures :
  1. Incidence rate of complication related to the investigational device [ Time Frame: Up to 30 days after surgery ]
    Complications related to the investigational device, for instance anastomotic leakage, anastomotic bleeding, excess fluid in abdominal drainage, CT scan verified abdominal abscess


Secondary Outcome Measures :
  1. Time to evacuation of the short-term implant [ Time Frame: About 2 weeks after surgery ]
    The subject informs the clinical investigator and hand over the expelled short-term implant

  2. Time to first defecation [ Time Frame: Up to 30 days after surgery ]
    The subject informs the clinical investigator when this occurs

  3. Time to first intestinal sounds [ Time Frame: Up to 30 days after surgery ]
    The subject informs the clinical investigator about when the intestine begin to murmur, and the clinical investigator will check the sound with a stethoscope

  4. Time to passage of gas [ Time Frame: Up to 30 days after surgery ]
    The subject informs the clinical investigator when it occurs

  5. Number of postoperative interventions related to the investigational device [ Time Frame: Up to 30 days after surgery ]
    The clinical investigator notes the interventions after surgery related to the use of device, for instance, CT scan, endoscopy examination and re-operation etc

  6. Anastomotic integrity pressure [ Time Frame: The operation day ]
    To confirm that the two anastomotic rings are properly locked to each other, measure integrity pressure through catheters connected to DMC (if DMC is applied). By infusing air into the closed space adjacent to the anastomosis via on catheter and concomitantly camping the other three catheters. When the pressure in the closed space exceeds the contact-induced closure by the joined intestinal segments, the pressure abruptly dropped and is defined as integrity pressure

  7. Time of surgery [ Time Frame: The operation day ]
    The time to complete the operation


Other Outcome Measures:
  1. Hemoglobin [ Time Frame: Up to 30 days after surgery, when needed ]
    Blood tests to detect potential anastomotic leakage

  2. WBC (white blood cell) [ Time Frame: Up to 30 days after surgery, when needed ]
    Blood tests to detect potential anastomotic leakage

  3. Physical examination [ Time Frame: Up to 30 days after surgery ]
    Body temperature, palpation of abdomen etc

  4. Procedures and/or device related adverse events [ Time Frame: Up to 30 days after surgery ]
    The clinical investigator notes the adverse events, severity and the relation to the investigational device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age ≥18 years and ≤80 years.
  2. 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).
  3. Cognitive ability to take part in the study and understand the information he/she receives about participating in the study.
  4. The patient has signed a written informed consent.

Exclusion Criteria:

  1. Urgent medical condition requiring immediate care.
  2. Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or severe dissemination (metastases) of cancer.
  3. Stenosis or other obstructions in the anal passage.
  4. Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis.
  5. Health condition classified as ASA III - VI .
  6. Albumin level less than 35 g/l.
  7. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease).
  8. Disease that requires more than one anastomosis during the surgical procedure.
  9. Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery.
  10. Contraindications to general anaesthesia.
  11. Perioperative detection of extreme variants of intestinal diameters or wall thickness.
  12. 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.
  13. BMI > 35.
  14. Myocardial infarct ≤ 6 months or sever heart disease.
  15. Severe embolic disease.
  16. Other conditions which surgeons think the patient should be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404934


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 2000032
Sponsors and Collaborators
Carponovum AB
Fudan University
Investigators
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Principal Investigator: Sanjun Cai, MD, PhD Fudan University
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Responsible Party: Carponovum AB
ClinicalTrials.gov Identifier: NCT03404934    
Other Study ID Numbers: CREX-005
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carponovum AB:
Adaptive anastomosis
C-REX
Colorectal cancer