No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 – 70
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
250 (estimated)
Sponsor
Colospan Ltd. · Industry
Who this trial is looking for
This trial is looking for patients with rectal cancer who are scheduled for surgery. Participants will receive the CG-100 device to help reduce the need for a stoma during their operation.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 22 and 70 years old.
I have been diagnosed with colorectal cancer.
I am scheduled for elective surgery that involves mesorectal excision.
I will need to have an anastomosis created during my surgery.
I am going to have bowel preparation before my surgery.
I have been informed about the study and agree to participate.
I am willing to follow up as required by the study.
You may not be able to join if
I have an active infection.
I have had major surgery in the last 45 days.
I have a serious medical condition classified as ASA > 3.
I have low albumin levels.
I have bowel obstruction or related issues.
I have a bleeding disorder or am immune suppressed.
My BMI is 40 or higher.
I am pregnant or nursing.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. The patient is willing to comply with protocol-specified follow-up evaluations
2. 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.
3. Patie…
Inclusion Criteria:
1. The patient is willing to comply with protocol-specified follow-up evaluations
2. 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.
3. Patient is diagnosed with colorectal cancer
4. 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
5. Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
6. Patient is scheduled to undergo mechanical bowel preparation
7. 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:
1. Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
2. 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).
3. Patients with ASA classification \> 3
4. Albumin \< 30 g/liter
5. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
6. Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
7. BMI ≥ 40
8. Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
9. The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
10. Patient has been taking regular systemic/ steroid medication in the last 6 months.
11. Patients is taking antimetabolites or antiplatelet agents.
12. Patient has preexisting sphincter problems
13. Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
14. Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
15. Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
16. 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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