RecruitingNot Applicable

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

United States250 participantsStarted 2020-06-23

Plain-language summary

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

Age range22 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

Change in Stoma creation rate

Timeframe: 39 Weeks

Incidence of complications

Timeframe: 39 Weeks

NCT IDNCT04184973

SponsorColospan Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Jonathan Elsner, PhD, MBA

Who can participate

Age range22 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.