CG-100 Clinical Study
The clinical study is currently enrolling patients to assess the safety and effectiveness of the CG intraluminal bypass device in colorectal and coloanal anastomoses. The study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing the CG-100 Intraluminal bypass device to a diverting stoma, the current standard of care treatment for colorectal surgery (Clinicaltrials.gov)
This is a multi-center randomized study, so patients who meet study requirements and agree to enter the study are randomized to either be treated with the CG-100 intraluminal bypass device or to receive a diverting stoma. Patients will be followed up for up to 39 weeks after surgery.
CG-100 Clinical study eligibility
If you are a rectal cancer patient between the ages of 22 and 65, and expect to undergo a colorectal surgery, you may qualify for our research study. This is an FDA-regulated clinical study, and specific criteria must be followed to determine who is eligible for inclusion.
Limited space is available and not all types of Colorectal cancer and surgeries are suitable for this study.
We are enrolling participants now at medical facilities at the following locations:
- AdventHealth- Orlando Florida
- Henry Ford Hospital- Detroit Michigan
- Miriam Hospital- Providence Rhode Island
- University of Louisville Hospital- Louisville Kentucky
- University of Colorado Anschutz Medical Campus- Aurora Colorado