Cook Medical said it started a multi-center clinical trial of its Evolution esophageal stent.
The study is designed to test the possibility of removing the self-expanding, covered metal stent after treatment of malignant and benign strictures including strictures, fistulas or perforations.
The single-arm study is expected to enroll 130 patients who are slated to be followed for the up-to-6-month duration of the stent implantation. Some patients are due to have a 30-day follow-up after stent removal. The principal investigator is Dr. John Vargo, chairman of gastroenterology & hepatology at the Cleveland Clinic, according to a press release.
“We are very excited to see where this study takes us. We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal diseases,” Cook Medical endoscopy global leader Barry Slowey said in prepared remarks.