Annual Report 2018
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 Center for New Surgical and Endoscopic Development for Exploratory Technology (NEXT) was founded in the National Cancer Center Hospital East on May 8, 2017. It provides stateof-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-theart medical care.
- Developing next-generation medical devices and technologies based on clinical needs.
- Introducing 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 next-generation medical devices and technologies based on clinical needs.
The Team and What We Do
The NEXT Medical Device Innovation Center undertakes research and development on innovative medical devices in exploratory technology based on clinical needs in industryacademia-government and medical-engineering collaboration. Especially, we target instruments and devices used in/around the endoscopic and laparoscopic surgery fields. We promote device development in partnership with medical device businesses, "monozukuri" (manufacturing) companies, academia, and the Chiba area. Furthermore, we support clinical trials and act as an advanced incubation facility providing training for surgeons and disseminating information.
Research activities
The NEXT Medical Device Innovation Center has undertaken 23 research and development collaborations with industry and academia partners. Especially, we have developed artificial intelligence (AI) applications for the medical field. The "Constructing 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, the center constructed a new system which digitalizes surgical techniques and judgements, and stored them in the database for improved efficiency and safety in endoscopic surgery. We aim for the application of the data analyzed through deep learning to develop surgical robots and evaluate medical devices. We also have developed AI applications for endoscopic diagnosis. In addition, we have developed a surgical robot for laparoscopic surgery, a novel endoscopy system "Oxygen Saturation Imaging Endoscopy", and training devices for laparoscopic surgery.
Furthermore, we started collaboration with venture companies in the development of medical devices from the idea of matching clinical needs and engineering seeds. To promote the collaboration, we held the "Medical device innovation in Kashiwanoha" symposiums on June 26 and December 4.
Clinical trials
1) Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
2) Clinical evaluation trial about prediction of treatment effect of chemotherapy or chemoradiotherapy for gastrointestinal cancer using oxygen saturation imaging endoscopy.
3) Clinical trial of biodegradable stent (BD-stent) for patients with refractory benign esophageal stricture.
Education
We held training seminars on the latest endoscopic surgeries such as transanal total mesorectal excision (taTME) once a month to improve surgeon's surgical techniques. We also held "Biodesigner professional course" seminars in collaboration with "Biodesign Japan" to develop human resources capable of creating innovative medical devices.
Future prospects
We established a system for proof of concept (POC) and clinical trials in the promotion of and support for medical device development. We also established a system for collaboration with venture companies in addition to "monozukuri" (manufacturing) companies.
List of papers published in 2018
Journal
1. Nishimoto W, Kawahira H, Shimomura Y, Nishizawa Y, Ito M. A standing posture support device that reduces laparoscopic surgeons' occupational lower limb stress. Minim Invasive Ther Allied Technol, 28:151-156, 2019
2. Kurosawa M, Takamatsu T, Kawano H, Hayashi Y, Miyahara H, Ota S, Okino A, Yoshida M. Endoscopic Hemostasis in Porcine Gastrointestinal Tract Using CO2 Low-Temperature Plasma Jet. J Surg Res, 234:334-342, 2019
3. Sakai Y, Takemoto S, Hori K, Nishimura M, Ikematsu H, Yano T, Yokota H. Automatic detection of early gastric cancer in endoscopic images using a transferring convolutional neural network. Conf Proc IEEE Eng Med Biol Soc, 4138-4141, 2018
4. Mori Y, Kudo SE, Misawa M, Saito Y, Ikematsu H, Hotta K, Ohtsuka K, Urushibara F, Kataoka S, Ogawa Y, Maeda Y, Takeda K, Nakamura H, Ichimasa K, Kudo T, Hayashi T, Wakamura K, Ishida F, Inoue H, Itoh H, Oda M, Mori K. Real-Time Use of Artificial Intelligence in Identification of Diminutive Polyps During Colonoscopy: A Prospective Study. Ann Intern Med, 169:357-366, 2018
5. Kudo T, Saito Y, Ikematsu H, Hotta K, Takeuchi Y, Shimatani M, Kawakami K, Tamai N, Mori Y, Maeda Y, Yamada M, Sakamoto T, Matsuda T, Imai K, Ito S, Hamada K, Fukata N, Inoue T, Tajiri H, Yoshimura K, Ishikawa H, Kudo SE. New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study). Gastrointest Endosc, 88:854-864, 2018