CG-100 Clinical Study

If you are a rectal cancer patient between the ages of
22-65 planned to undergo a colorectal surgery
and would like to be considered for the study, click here.

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.

FAQ

If you are eligible and decide to voluntarily participate in the CG-100 study, you will receive the follow-up care that goes with being part of a clinical study. If you are randomized to the device group, the CG-100 intraluminal Bypass Device may lower the likelihood that you will require a stoma, and associated complications. The clinical study will evaluate whether CG-100 provides these potential benefits. While there is no guarantee that you will benefit directly from this research, information obtained in this clinical research study may contribute to a greater knowledge about the use of this device or to the development of a new treatments
As with any medical treatment, there are associated risks. The risks can be categorized as risks related to colorectal surgery, risks related to stoma, risks related specifically to the study device, and risks related to the tests performed specifically for the study. You will learn more about the potential risks and discomfort during the study screening and informed consent process. In addition, please be aware that after receiving the CG-100 Intraluminal Bypass Device your physician may still need to conduct a diverting stoma procedure, or other procedure, if they believe that there is still a risk of anastomotic leakage after the device is removed
Yes, the CG-100 has been studied in a previous human pilot clinical study. The purpose of this study is to further evaluate the safety and efficacy (potential risks and benefits) of CG-100 in a larger number of patients.

Participation in the CLD-075 clinical study should have no cost to the patient and may include the appropriate co-pay as per individual insurance coverage.

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

If you are a rectal cancer patient between the ages of
22-65 planned to undergo a colorectal surgery
and would like to be considered for the study, click here.