Ongoing 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 reseach. There are currently three studies utilizing Cook’s EchoTip ProCore ultrasound needles: One in the EUS field and two in the relatively new focus area of endobronchial ultrasound (EBUS). Additionally, Cook’s Evolution stents are featured in two current studies.
ASPRO study results featured at UEG Week
Enrollment is now complete for the ASPiration vs. PROcore (ASPRO) study, an international randomized multicenter trial. Selected data from this study was made available for UEG Week 2016. In the study, patients were randomized between EUS-guided tissue acquisition using a 25 gauge fine needle aspiration (FNA) device and a 20 gauge fine needle biopsy (FNB) device (EchoTip ProCore needle). Coordinated by the Erasmus University Medical Center in Rotterdam, this study compares the diagnostic accuracy of the 25 gauge vs. the 20 gauge needles measured against a gold standard diagnosis.
Exploring pulmonary EBUS
The first of the pulmonary EBUS studies is a multicenter randomized trial comparing Cook’s standard 22 gauge EchoTip with our new 22 gauge EchoTip ProCore EBUS needle with known or suspected mediastinal adenopathy. The second EBUS study is a multicenter randomized trial comparing the sample quality of the EchoTip 22 gauge, EchoTip 25 gauge and EchoTip ProCore 25 gauge for diagnosis of granulomatous lesions (sarcoid) in the mediastinal and hilar lymph nodes.
Two ongoing studies feature Cook Evolution stents
Results of two studies featuring Cook Evolution stents are expected later this year or early next. The CLARITY study, a prospective, multicenter clinical study being conducted to support a benign indication in the US for the Evolution Esophageal Stent – Fully Covered. The study may allow us to claim “removability” for the Evolution Esophageal Stent – Fully Covered in the US market.
The second is a study designed to gain US market clearance for the use of the Evolution Biliary Stent – Fully Covered in patients with malignant biliary obstruction. This international study involves sites in the US, Canada and Europe.
|UEG Week 2016
|Amsterdam Live Endoscopy 2016