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The Colospan Device: CG-100 Clinical Study

The CG-100 is being evaluated as an alternative to ostomy bags for patients with colorectal cancer

As a patient with colorectal cancer, your oncologist and surgeon may recommend surgery to remove the cancerous part of your bowel. A dangerous complication of this surgery is internal leakage of digestive waste where the two healthy ends of your bowel are surgically reconnected. As a result, an ostomy bag is often used to temporarily divert the waste outside the body from an opening in your abdomen. In recognition that living with an ostomy bag can present daily challenges that can affect overall health and quality of life for colorectal patients, an alternative has been developed and is being evaluated in the CG-100 clinical study.

What is an Ostomy?

An ostomy is often required for patients undergoing surgery for colorectal cancer

Surgeons create a hole – called a stoma – in the abdomen that brings the small intestine to the surface.
Digestive waste is then released directly from the small intestine into an ostomy bag.
The bag, which sits outside of the body, is currently considered the standard treatment for colorectal surgeries where internal leakage is a concern.
A follow-up surgery is performed in 2-12 months to remove the ostomy bag and reconnect the bowel.

Having an ostomy bag can lead to medical complications, greatly reduce quality of life and extend recovery time.

What is being evaluated in the study?

The study is assessing the safety and effectiveness of the Colospan Device and whether it can reduce the need for an ostomy bag and its related complications. Patients will be randomized to receive treatment with either the Colospan Device or an ostomy bag. All patients will be followed for up to 39 weeks after surgery. At scheduled visits, you will be asked questions about your recovery and quality of life, as well as complete medical assessments.

What is the Colospan Device?

The Colospan Device is a temporary bypass that may have several potential benefits compared to an ostomy bag:

Increased quality of life

Ability to participate in more day-to-day physical activities

Decreased need for additional surgery

Faster recovery time

More than 100 patients have received the Colospan Device in clinical studies in Europe and the U.S.

How does the Colospan Device work?

The Colospan Device is a flexible silicone tube that is positioned inside the bowel, extending above and below the site of reconnection to prevent internal leakage. After about 10 days, when the risk for internal leakage is reduced and the integrity of the resection can be confirmed, the Colospan Device is removed without surgery.

What are the differences between the Colospan Device and an ostomy bag?

Colospan Device

One surgery

Digestive waste passes through the device and is discharged normally through the anus

Device is removed after approximately 10 days

Following removal, patients have the potential to return to normal life quickly

Ostomy Bag

Two surgeries (additional surgery for stoma reversal)

Digestive waste is discharged into an ostomy bag through a hole (stoma) in the abdomen without voluntary control

Stoma remains in place for 2-12 months

Living with a stoma can impact quality of life and lead to health issues

Individual results may vary. Be sure to discuss your individual symptoms, diagnosis and treatment with your surgeon.

Where is the CG-100 available?

Henry Ford Hospital - Detroit Michigan
Miriam Hospital - Providence Rhode Island
University of Colorado Anschutz Medical Campus- Aurora Colorado
University of Utah Health - Salt Lake City Utah
University of California - Irvine California
Kaiser Permanente Medical Center - San Diego California

Your participation in the CG-100 clinical study may provide benefits for others affected by colorectal cancer.

To find out if you are eligible to participate in this study and for more information fill-in the form:

For US – CAUTION: Investigational Device. Limited by US law to investigational use only.

All information provided is confidential and will not be given or sold to any other agency without prior consent.

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