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Tests treatment safety and results for Rectal Cancer
Official title Efficacy and Safety of the CG-100 Intraluminal Bypass Device
ClinicalTrials.gov ID: NCT04184973
What this study is testing
- What it's testing
- A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- 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...
- 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...
- Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
You likely can't join if
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- Major surgical or treatment procedures within 45 days prior to this study or planned surgical or treatment procedures within 6 months of entry into...
- 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...
- Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
See the full eligibility 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...
- 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 treatment procedures within 45 days prior to this study or planned surgical or treatment procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Detroit, Michigan, United States
- Providence, Rhode Island, United States
- Salt Lake City, Utah, United States
- Hamburg, Germany
- Beersheba, Israel
- Milan, Lombardy, Italy
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Detroit, Michigan, United States; Providence, Rhode Island, United States; Salt Lake City, Utah, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.