French medical device company SafeHeal has reported positive results from a clinical study conducted for its Colovac bypass sheath in patients undergoing colorectal surgery.
The first-in-human single-arm 15-patient study was aimed at evaluating the safety and efficacy of the Colovac device in the protection of colorectal anastomosis in adult patients.
During the study phase, patients received a Colovac implant for a period of two weeks, in place of a diverting ostomy.
The minimally invasive and fully reversible device can remain in place until the completion of the body’s natural healing and tissue repair processes. During an endoscopic procedure, it can be easily removed avoiding a second surgical intervention.
SafeHeal noted that appropriate protection against direct contact with faeces at the time of implant was accomplished in all cases.
The placement, as well as retrieval procedures, have also proven to be safe and effective.
SafeHeal CEO Karl Blohm said: “The study shows that our Colovac bypass device can successfully reduce the number of diverting ostomies for patients undergoing colorectal surgery.
“The trial results will allow us to design the next clinical phase as well as our strategy for regulatory approvals in the EU and the US.”
The study found that 67% of participating patients successfully avoided diverting ostomies. Furthermore, it was revealed that Colovac might improve the quality of life of surgery patients.
The study was conducted at two hospitals in France (Institute of Image-Guided Surgery in Strasbourg in collaboration with the CHRU Strasbourg and Saint Antoine Hospital, APHP in Paris) and at UZA in Belgium.
The Colovac device, an endoluminal bypass sheath, is placed in the colon following rectal resection and is intended to suppress the amount of contact that faecal matter has with the colorectal anastomotic site.