Cook Medical has begun a US clinical trial to evaluate the possibility of removing a new Evolution esophageal fully covered stent after malignant and benign strictures have been treated.
In this clinical study, design of the Evolution esophageal fully covered stent has been modified to accommodate retrieval. The prospective, single-arm study will also assess the use of the new device in esophageal conditions, including strictures, fistulas, perforations or leaks.
The clinical study will enroll 130 patients at up to 15 sites in the US and the patients will be followed for the duration of stent placement up to six months. After removal of the endoscopic stent, specified patients will have a 30-day follow-up that will complete his or her enrollment.
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. Patients who have an esophageal fistula, perforation or leak can also be included in the study.
Cook Medical Endoscopy division global leader Barry Slowey noted the company is very excited to see where this study takes it.
"We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal diseases," Slowey added.