SafeHeal, an innovator in the field of digestive surgery, has concluded its first-in-human clinical study for its novel Colovac bypass sheath in patients undergoing colorectal surgery.
The single-arm 15-patient study was aimed at evaluating the safety and efficacy of Colovac in the protection of colorectal anastomosis in adult patients who were scheduled to receive a diverting ostomy, following colorectal surgery.
During the study phase, patients received a Colovac implant for two weeks, in place of a diverting ostomy. In all cases, appropriate protection against direct contact with feces during the implant period was accomplished. The placement and retrieval procedures have also proven to be safe and effective. Sixty-seven percent of participating patients successfully avoided diverting ostomies and returned home without the artificial anus that often accompanies such surgeries. Results of the trial show that the device might improve the quality of life of surgery patients, who can return to their normal life shortly after treatment.