DETROIT, Dec. 9, 2020 /PRNewswire/ -- Colospan Ltd. today announced that Detroit-based Henry Ford Hospital is the first in the U.S. to perform an investigational procedure using the CG-100™ bypass device to assess its ability to reduce the need for stoma creation in rectal cancer patients undergoing colorectal or coloanal surgery. CG-100 is a temporary protective bypass device which is being evaluated as an investigational treatment to determine whether it can reduce the need for a diverting stoma and its related complications. Henry Ford Hospital is the only site in Michigan – and just one of 12 sites nationwide – that will be enrolling colorectal cancer patients in the clinical trial.
Colorectal surgery typically includes the procedure of colorectal anastomosis where the diseased section of the colon or rectum is removed, and the two healthy segments on either side of it are reattached.
Leakage of colon content from the anastomotic site into the abdominal cavity is a dangerous complication, increasing hospitalization time, re-operation, and mortality.
To prevent leakage, surgeons often create a small opening called a stoma on the surface of the abdomen, to divert the flow of waste from the bowel into an external bag. Living with a diverting stoma can be overwhelming and uncomfortable, but a stoma is currently considered the standard treatment for almost 70% of rectal and high-risk colon resections.
"There are limited options for patients who undergo a low resection of the colon," said Craig Reickert, M.D., division head of Colon and Rectal Surgery at Henry Ford Cancer Institute. "Because the CG-100 device allows us to perform only a single minimally invasive procedure, the hope is that it can safely reduce the need for stoma and allow for a more comfortable and easy recovery, which increases the patient's quality of life and allows them to avoid the complications that some encounter with a stoma."
People 22-65 years old who are scheduled to undergo coloanal or colorectal surgery with stoma placement due to colorectal cancer can inquire about the study by visiting www.stomachoice.com or by calling (313) 916-4477.
In the U.S., CG-100™ from Colospan Ltd. is an investigational device for patients with colorectal cancer who require an anastomosis and are to receive a protective stoma under routine clinical practice. The CG-100 Intraluminal Bypass Device is a silicone tubular sheath that is introduced into the colon using a designated delivery system. The protective sheath is held in place by a mechanism that consists of inflatable balloons and an extra-luminal ring which encircles the colon, which prevents the sheath from moving downstream while protecting the anastomosis site. After approximately ten days, when the risk for anastomotic leakage is reduced and the anastomosis integrity is confirmed, the sheath and ring are removed without any surgical intervention. The CG-100 Intraluminal Bypass Device has been approved for use in the European Union (EU), and in Israel. To learn more about CG-100, please visit www.stomachoice.com.
About the CG-100 Clinical Trial
The CG-100 study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing CG-100 to stoma, the current standard of care treatment for low anterior resection of the colon.
About Colospan Ltd.
Colospan Ltd. is a medical device company focusing on the development of novel and proprietary solutions for colorectal surgery. The company is dedicated to addressing the clinical and economic consequences of anastomotic leaks, the first and foremost challenge in colorectal surgery. Colospan's team consists of seasoned professionals in marketing, sales and development of surgical devices for colorectal surgery, supported by key opinion leaders from Europe and the United States. The CG-100 is not approved for sale in the United States and is limited to investigational use. For more information, please visit www.colospan.com
CAUTION Investigational device. Limited by United States law to investigational use.
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Jonathan Elsner VP Clinical Affairs, US