Cook Medical has initiated a clinical study in the U.S. to evaluate the removability of a new Evolution® Esophageal Fully Covered Stent. This is the first multicenter U.S. study to evaluate the possibility of removing a self-expanding metal stent after malignant and benign strictures have been treated. The stent design used in the study has been modified to accommodate retrieval. The study will also evaluate the use of the device in esophageal conditions, including strictures, fistulas, perforations or leaks.
The study, led by Principal Investigator Dr. John Vargo MD, MPH and chairman of Gastroenterology and Hepatology at the Cleveland Clinic, is a prospective, single-arm study. Patients can be enrolled in the study when they require a stent for an obstruction that is caused by an intrinsic or extrinsic malignancy or a refractory benign esophageal stricture. Also, patients that have an esophageal fistula, perforation or leak can be included in the study. There are additional eligibility criteria for the study.
"Defining the role of removable stents in benign and malignant esophageal disorders is still a quandary for clinicians," said Dr. Vargo, "This multicenter study which involves many of the leading centers in therapeutic endoscopy, should help answer this question."
The Evolution Esophageal study will be conducted at up to 15 sites across the U.S. and will enroll 130 patients. Patients will be followed for the duration of stent placement up to six months. After endoscopic stent removal, specified patients will have a 30-day follow-up that will complete his or her enrollment.
"We are very excited to see where this study takes us," said Barry Slowey, global leader of Cook Medical's Endoscopy division. "We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal diseases."