Bloomington, Ind.-based Cook Medical has launched a clinical trial to determine the removability of its Evolution Esophageal Fully Covered Stent. The device is used to maintain patency of malignant esophageal strictures and seal tracheoesophageal fistulas, perforations and leaks.
The prospective, single-arm study — led by a paid consultant for Cook Medical working at the Cleveland Clinic — will evaluate 130 patients at 15 centers across the U.S. Subjects will be followed for up to six months after placement of the self-expanding metal stent, which has been modified with a lasso loop and grasping features on both ends that facilitate removal. Following the stent’s removal, the patients will be followed for another 30 days.
Cook plans to finish enrolling and treating patients by the end of this year, with study results by mid-2015, said spokeswoman Caitlin Davis.
“We are very excited to see where this study takes us, said Barry Slowey, global leader of Cook’s endoscopy division. “We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal disease.”
Data generated by the study will be used to seek regulatory approval of the removable stent. “Currently, in the U.S., metal stents are only FDA-cleared for permanent placement in malignant strictures of the esophagus,” Davis said. — Lena Freund
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