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Annual Report 2017

NEXT Medical Device Innovation Center

Masaru Konishi, Masaaki Ito, Nobuyoshi Takeshita, Shigekazu Nagashima, Tomonori Yano, Yusuke Yoda, Shinichiro Takahashi, Norio Yamamoto, Yuko Tanabe

Introduction

 The NEXT (Center of New Surgical and Endoscopic Development for Exploratory Technology) was founded in the National Cancer Center Hospital East (NCCHE) on May 8, 2017. It provides state-of-the-art medical care to patients and develops medical devices and technologies, especially in surgical and endoscopic fields with the following aims:

- Providing currently available state-of-the-art medical care

- Developing the next-generation medical devices and technologies based on clinical needs

- Introducing the developed medical devices and technologies to clinical practice

- Developing the next generation of leaders in the cancer-care field

 The NEXT Medical Device Innovation Center is included in the NEXT, and develops the next-generation medical devices and technologies based on clinical needs.

Our team and what we do

 The NEXT Medical Device Innovation Center conducts research and development activities on innovative medical devices in exploratory technology based on clinical needs in industry-academia-government and medical-engineering collaboration. Especially, it targets instruments and devices used in/around endoscopic and laparoscopic surgery fields. It promotes the device development in partnership with medical device business, "monozukuri" (manufacturing) companies, academia, and Chiba-area. Furthermore, it supports it in clinical trials, and acts as an advanced incubation facility with providing training of surgeons and sending information.

"NEXT FOR DREAM"

 The NEXT Medical Device Innovation Center develops innovative medical devices which can realize dreams from a viewpoint of patients, medical professions, and business. For realizing dreams, our center promotes, supports, and incubates medical device innovation.

Research activities

 The NEXT Medical Device Innovation Center conducts research and development activities focusing on artificial intelligence (AI) application to the medical field. The research and development "Constructing a database of tacit knowledge and its application for surgical device innovation in laparoscopic surgery" was adopted by the Japan Agency for Medical Research and Development (AMED) as a funding support program. During the period of this program, through March 2019, our center constructs a new system which digitalizes surgical techniques and judgements, and stores them into the database for the improved efficiency and safety in endoscopic surgery. We aim at application of the data analyzed with deep learning into the development of surgical robots and evaluation of medical devices. We also conduct research on AI application to endoscopic diagnosis.

 Furthermore, we promote the development of medical devices by matching the clinical needs with the seeds of technology. Four needs were selected from 75 clinical needs in the NCCHE through discussion on technology, pharmaceutical affairs law, and business. We started collaborations with companies on the themes matched with the seeds of technology after presentation of those four needs in C-square EXPO'17 held in Chiba.

Clinical trials

1) A phase II study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery

2) A clinical evaluation trial about prediction of treatment effect of chemotherapy or chemoradiotherapy for gastrointestinal cancer using oxygen saturation imaging endoscopy

Education

 We held training seminars on the latest endoscopic surgeries such as transanal total mesorectal excision (TaTME) for improving surgeons' surgical techniques. We also held "Biodesigner professional course" seminars in collaboration with "Japan Biodesign" for developing human resources capable of creating innovative medical devices.

Future prospects

 We establish a system for a proof of concept (POC) and clinical trials in the promotion and support for the medical device development. Furthermore, we develop medical devices in collaboration with venture companies in addition to "monozukuri" (manufacturing) companies.

List of papers published in January 2017 - March 2018

Journal

1. Nishigori H, Ito M, Nishizawa Y. A novel transanal tube designed to prevent anastomotic leakage after rectal cancer surgery: the WING DRAIN. Surg Today, 47:513-520, 2017

2. Kawai T, Hayashi H, Nishizawa Y, Nishikawa A, Nakamura R, Kawahira H, Ito M, Nakamura T. Compact forceps manipulator with a spherical-coordinate linear and circular telescopic rail mechanism for endoscopic surgery. Int J Comput Assist Radiol Surg, 12:1345-1353, 2017

3. Yano T, Yoda Y, Nomura S, Toyosaki K, Hasegawa H, Ono H, Tanaka M, Morimoto H, Horimatsu T, Nonaka S, Kaneko K, Sato A. Prospective trial of biodegradable stents for refractory benign esophageal strictures after curative treatment of esophageal cancer. Gastrointest Endosc, 86:492-499, 2017

4. Hamabe A, Ito M. A three-dimensional pelvic model made with a three-dimensional printer: applications for laparoscopic surgery to treat rectal cancer. Tech Coloproctol, 21:383-387, 2017

5. Yano T, Kasai H, Horimatsu T, Yoshimura K, Teramukai S, Morita S, Tada H, Yamamoto Y, Kataoka H, Kakushima N, Ishihara R, Isomoto H, Muto M. A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer. Oncotarget, 8:22135-22144, 2017