SafeHeal Starts First-in-Human and CE-Mark Clinical Study of Endoluminal Bypass Sheath
February 22, 2018
SafeHeal, developer of the Colovac device, has enrolled the first five patients in its CE mark study. The Colovac device is a unique endoluminal bypass sheath placed in the colon following rectal resection, aimed at significantly improving the recovery of patients after colorectal surgery without the need for an ostomy.
This prospective, single-arm, 15-patient study, was approved at the end of 2017 by the French health authority ANSM. It aims to evaluate the safety and efficacy of Colovac for the protection of colorectal anastomosis in adult patients initially scheduled to receive a diverting ostomy as per standard of care, following colorectal surgery. In the study, patients receive a Colovac device in lieu of the ostomy. The study is currently enrolling more patients at two hospitals in France (Strasbourg and Paris).
The two first procedures were carried out at the Institute of Image-Guided Surgery in Strasbourg in collaboration with the CHRU Strasbourg. They were performed by Dr. Antonio D’Urso, M.D., digestive surgeon and principal investigator of the study, and Pr. Mutter, M.D., Ph.D., head of liver and gastrointestinal surgery and co-director of IRCAD, one of the world’s most famous surgery training centers. The three further procedures were performed by Pr. Jérémie Lefèvre M.D., Ph.D., professor of digestive surgery at Hospital Saint-Antoine in Paris.
