Colovac is an innovative colorectal anastomosis protection device designed as an effective alternative to diverting ileostomy to support healing after colorectal procedures.

The device is placed at the time of the rectal resection surgery and is fully reversible. Colovac is designed to remain in place for 10 days until the body’s natural healing and tissue repair processes are complete, after which it is removed by an endoscopist without the need for a second surgical intervention.

Currently, Colovac is being evaluated in the SAFE-3CV Clinical Study—a prospective, single-arm, non-randomized trial assessing anastomotic healing alongside the standard-of-care treatment for rectal cancer. Patient enrollment is ongoing in the U.S. and Europe.

Clinical study participants must be 18 years of age or older and referred for a rectal cancer resection with a planned diverting ileostomy.  

The study, currently enrolling, will assess outcomes with the Colovac device as compared to the standard of care diverting ileostomy. The ultimate objective is to establish Colovac as a safe, effective alternative to diverting ileostomy.

For the majority of patients, Colovac is expected to eliminate the need for a diverting ileostomy and a second ostomy reversal surgery. This enables patients to resume normal activity after their cancer resection surgery without the stigma and complications associated with an ostomy procedure.

Participation is free, and patients may receive up to $1,200 for completing all required follow-ups.

The Institutional Review Board of each participating Clinical Study Site has assessed the risks associated with the SAFE-3CV protocol and that appropriate steps have been taken to protect the rights and welfare of humans participating in the study.

Karen Zaghiyan, MD
Cedars-Sinai Medical Center

Justin Maykel, MD
UMASS Memorial Medical Center