Efficacy and Safety of the CG-100 Intraluminal Bypass Device

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    168
  • sponsor
    Colospan Ltd.
Updated on 30 November 2021

Summary

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

Description

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.

Details
Condition Colorectal Cancer, Rectal Cancer, rectal neoplasm, rectal tumor, rectal neoplasms, rectal carcinoma, Rectal/Anal, Rectal/Anal, Rectal/Anal, Rectal/Anal, Rectal/Anal, Rectal/Anal, Rectal/Anal, Rectal/Anal
Treatment CG-100 Intraluminal Bypass Device, Stoma, Stoma
Clinical Study IdentifierNCT04184973
SponsorColospan Ltd.
Last Modified on30 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient is willing to comply with protocol-specified follow-up evaluations
Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed
Patient is diagnosed with colorectal cancer
Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation
Patient is scheduled to undergo mechanical bowel preparation
The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB)

Exclusion Criteria

Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion)
Patients with ASA classification > 3
Albumin < 30 g/liter
Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
BMI 40
Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery
The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor
Patient has been taking regular systemic/ steroid medication in the last 6 months
Patients is taking antimetabolites or antiplatelet agents
Patient has preexisting sphincter problems
Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis
Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test
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