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Annual Report 2019

Division of Surgical Technology

Masaaki Ito, Takahiro Kinoshita, Nobuyoshi Takeshita

Introduction

 The main purpose of the Division of Surgical Technology is to develop surgical devices that are truly necessary, to deliver them to the clinical fields, and to prove their safety and efficacy through clinical trials. The three main elements of our innovation are creating devices reflecting true needs in the medical field, practicing with the devices in clinical trials and connecting our innovations to a wider world.

The Team and What We Do

 By cooperation with the NEXT (Center for New Surgical and Endoscopic Development for Exploratory Technology), we started promoting surgical device development consisting of clinical need selection, prototype design, POC (Proof of Concept) establishment, validation, and clinical trials. In addition, we will create an innovative medical development roadmap by establishing a hub for surgical device development in National Cancer Center Hospital, East (NCCE) and building up a clinical supportive team for early-phase surgical device development.

Research activities

1. Cooperation with the NEXT

 We have strengthened the system and surgical device development in cooperation with the NEXT, based on discussion among experts consisting of surgeons and coordinators for surgical innovation, intellectual property and pharmaceutical affairs.

2. Research and development of devices for reducing the psychological stress of surgeons

 We have verified the effect of a novel device with natural sound sources for reducing the psychological stress of surgeons by conducting joint research with the university of Tokyo and as a result, we were able to see research outcomes. (The research is now complete.)

3. Innovative surgical robotic system developed by NCC-certified venture company, A-Traction

 In collaboration with an NCC-certified venture company, A-Traction, established in 2015, we have developed an innovative surgical robotic system. The system can support laparoscopic surgery as an assistant in addition to a surgeon. After the prototyping, we have advanced to verification for manufacturing approval.

4. Platform development for a system for clinical trial operations

 We completed the case registration and verification test for the efficacy of the anus tube “Wing drain” that we have developed.

5. Activity of regional cooperation group for surgical innovation, C-Square

 As a regional entity, we cooperated with Chiba Prefecture on the “Biodesign seminar” and “NEXT medical engineering-collaboration introduction seminar” to develop human resources for creating innovative medical devices in regional companies.

Clinical trials

Create supportive infrastructure for surgical innovation

 We aim to establish a clinical trials infrastructure for surgical innovation in the National Cancer Center Hospital East. Surgical clinical trials for our established device were promoted.

Education

 We held regular in-house seminars to teach surgical device innovation for the development of human resources.

Future prospects

 We aim to establish a clinical support team for early-phase surgical device innovation and to make a roadmap for surgical device innovation.

List of papers published in 2019

Journal

1. Hasegawa H, Tsukada Y, Wakabayashi M, Nomura S, Sasaki T, Nishizawa Y, Ikeda K, Akimoto T, Ito M. Impact of intraoperative indocyanine green fluorescence angiography on anastomotic leakage after laparoscopic sphincter-sparing surgery for malignant rectal tumors. Int J Colorectal Dis, 35:471-480, 2020

2. Kondo A, Nishizawa Y, Horikiri Y, Amemori H, Tsukada Y, Sasaki T, Kawai T, Daiko H, Ito M. A novel device designed to improve the operability of energy devices with foot pedals in endoscopic surgery: the Foot-Site Monitor. Surg Today, 49:965-970, 2019

3. Kitaguchi D, Takeshita N, Matsuzaki H, Takano H, Owada Y, Enomoto T, Oda T, Miura H, Yamanashi T, Watanabe M, Sato D, Sugomori Y, Hara S, Ito M. Real-time automatic surgical phase recognition in laparoscopic sigmoidectomy using the convolutional neural network-based deep learning approach. Surg Endosc, 2019