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Endoscopy
December 20th, 2017

What’s happening in Endoscopy clinical research: An update


Clinical studies are key to bringing more innovative treatment options to patients and physicians around the world. That’s why Cook Medical makes it a priority to remain actively involved in clinical research. Below are the latest updates on several ongoing research studies.

Evolution® Biliary stent studies
The major US study on the Evolution Biliary fully covered stent has been completed, with the last patient visit recorded early in 2017. The data analysis is being finalized, and a report is being prepared for FDA regulatory submission.

A manuscript reporting on the results of a study on the Evolution Biliary bare stent is being prepared with journal submission planned for early 2018.

Endoscopic ultrasound (EUS) study data being analyzed
Last year during UEG Week preliminary data from the ASPiration vs. PROcore (ASPRO) study was presented. This is an international randomized multicenter trial study comparing EUS-guided tissue acquisition using a 20 gauge fine needle biopsy (FNB) device (EchoTip ProCore® needle) and a 25 gauge fine needle aspiration (FNA) device (EchoTip® Ultra needle). The study finished enrollment with 615 patients included. Final results are being analyzed. Results expected at DDW 2018, with a publication to follow.

Endobronchoscopic ultrasound (EBUS) research results due in 2018
Two prospective multicentre randomized studies on EchoTip® EBUS needles have completed enrolment. The first study compared the sample quality of the EchoTip Ultra 22 gauge and EchoTip ProCore 25 gauge for diagnosis of granulomatous lesions (sarcoid) in the mediastinal and hilar lymph nodes. The second study compared Cook Medical’s EchoTip Ultra 22 gauge with our EchoTip ProCore 22 gauge needle with known or suspected mediastinal adenopathy. Analysis of the data is underway, with results anticipated in 2018.