Feasibility of a Newly Developed Thumb Control Device for Simultaneous Manipulation of the Endoscope and Treatment Devices in Endoscopic Submucosal Dissection: A Clinical Feasibility Study

Abstract

Background/aim: We developed a new device for the simultaneous manipulation of an endoscope and treatment devices, which we named the Smart Shooter®. The aim of this study was to validate the feasibility of using the Smart Shooter® in endoscopic submucosal dissection (ESD).

Methods: This pilot feasibility study conducted between March and June 2014 involved 20 consecutive patients who underwent ESD for superficial gastrointestinal neoplasia. The primary endpoint was a serious adverse event during the ESD procedure. The secondary endpoints were completion rate of ESD using the Smart Shooter® and a mechanical problem with the Smart Shooter® during ESD.

Results: A total of 20 patients underwent ESD for 23 lesions: 5 pharyngeal, 8 esophageal, 7 gastric, and 3 colonic lesions. There were no serious adverse events or mechanical problems during ESD. The completion rate of ESD using the Smart Shooter® was 82.6% (19/23).

Conclusion: ESD using the Smart Shooter® appears to be technically feasible.

Clinical trial registration: UMIN 000013710.