RecruitingNot applicable

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the CG-100 device is safe and can reduce the need for a stoma, an opening in the belly for stool to leave the body. It is for people with colorectal cancer having surgery to remove the rectum and nearby tissue.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You agree to attend the study’s follow-up visits and tests.
  • You are age 22–65, or age 66–70 with no more than one heart, blood vessel, metabolism, or lung condition treated with medicine.
  • You have cancer of the colon or rectum.
  • You have planned surgery to remove the rectum and nearby tissue, with the bowel reconnected no more than 10 cm from the anus.
  • Your surgeon would normally plan a protective stoma during this surgery.
  • You are scheduled to have your bowel cleaned out before surgery.
  • You understand the study, agree to its rules, and sign a consent form.

Who can't join

  • You have an infection at surgery, or serious bowel problems: blockage, trapped bowel, a hole, poor blood flow, infection inside the belly, cancer spread through the belly lining, or widespread inflammatory bowel disease.
  • You had a major surgery or procedure within the past 45 days, or plan one within 6 months of joining. Chemotherapy port placement and a tube placed in the ureter are exceptions. Extra procedures during the study surgery are also excluded, except an ileostomy (a stool opening) or removal of scar tissue.
  • Your ASA score, which rates health before surgery, is above 3; your blood albumin protein is below 30 g/L; or your body mass index (BMI) is 40 or higher.
  • You have a blood-clotting disorder, low platelets (blood cells that help stop bleeding), or a weakened immune system.
  • You regularly took steroids that affect the whole body in the past 6 months, or take antimetabolites (drugs that block cell growth) or antiplatelet drugs (drugs that keep platelets from sticking together).
  • You have problems with the muscle that controls stool, widespread disease in the pelvis, a past bowel reconnection in the pelvis, or many pouches in the lower colon seen on a CT scan.
  • You are in another drug or device study without the sponsor’s approval, or the study doctor believes another condition could make participation unsafe or affect the study data.
  • You are pregnant or breastfeeding. If you could become pregnant, you must have a negative pregnancy test within 7 days before surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. 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.

Study sites (6)

CA

CO

MI

  • Henry Ford Health System · Detroit, MI 48202Anna Nefcy · Study contact · 3139169387 · lnefcy1@hfhs.orgCraig Reickert, MD · Principal investigatorSurya Nalamati, MD · Sub-investigatorEdwin Itenberg, MD · Sub-investigatorMore trials in Detroit

RI

UT