Advertisement

Sa1964 FLEXIBLE ENDOSCOPIC DOUBLE BALLOON PLATFORM: FROM CONCEPT TO HUMAN FEASIBILITY TRIAL

      Background

      Despite the clear benefits and utility of Flexible Endoscopy (FE) in the diagnosis and therapy of GI disease. Inherent limitations exist in FE design and affects the ability to perform advanced therapeutic actions effectively and efficiently. Here, we present a report of a unique add-on technology in development – a double balloon platform that adds stability and improves endoscopic visualisation within existing FE systems. This technology began as a concept within the Minimally Invasive New Technologies (MINT) program of Weill Cornell Medicine / New York Presbyterian Hospital and here we report the results of the first human clinical feasibility registry study.

      Methods

      We report the development of the double-balloon device by a two-operator team from the first human case onwards (see figure 1). All 30 patients were scheduled to undergo routine surveillance colonoscopy (see figure 2). Key outcomes (ability to reach cecum, procedure time, inflation of balloons and complications) were prospectively reported for each patient sequentially.

      Results

      The first case was attempted in April 2017. Subsequently 29 colonoscopies were undertaken using the device and the study ended September 2017. In 5 patients the cecum was unable to be reached, in 1 of those patients this was not possible with the FE alone. This was primarily due to long, tortuous colon anatomy. Time to reach cecum was on average 13.4 minutes. No obvious trends were noted in other outcomes. No clinically significant complications were observed. 6 polyps were treated using the device successfully (in 2 patients).