Annual Report 2024
Department for The promotion of Medical Device Innovation
Masaaki Ito, Tomonori Yano, Nobuyoshi Takeshita, Keiichiro Nakajo, Hiroaki Sunakawa, Tetsuya Sakai, Kazuo Watanabe, Hiro Hasegawa, Shingo Sakashita, Toshifumi Tomioka, Tatsuya Ohnishi, Joji Sameshima, Mariko Kikuta, Miyo Takanashi, Yumi Kinebuchi, Daichi Kitaguchi, Kimimasa Sasaki, Shin Takenaka, Xue Zhao, Norihito Kosugi, Kazuyuki Okamura, Tadashi Miyamoto, Yuto Ishikawa, Satoshi Kaneta, Masami Namihira, Kenji Ohtsuka, Haruki Mitarai, Wang Yifan, Atsuki Tanaka, Koichiro Yoshida, Raito Suzuki, Yu Sasagawa, Yuriko Iyama, Miyuki Tanaka, Yoshiko Tomita, Tomoko Ohe, Yuko Hitomi, Yukari Nagatsuma, Yuka Takahashi, Yoshie Kasahara, Kayoko Ogawa, Nana Nagayama, Haruya Takasaki, Yuna Oikawa, Takehiro Ando, Shintaro Arakaki, Nobushige Takeshita, Nao Baba, Risa Tkai, Yoshitsugu Yanagida, Shuntaro Iuchi, Syun Takahashi, Machiko Kakihara, Miho Kushinobe, Atsuko Takahashi, Tomoko Takahashi, Yutaka Tomioka, Yasushi Nakamura, Tomoko Kongoji, Kosei Hamagashira, Yu Mizuno, Yasuyuki Yoshida, Norio Yamamoto, Mayumi Yamada, Kayo Suzuki, Megumi Kawakami, Kaho Kamijo, Yoshihiro Haruki, Yoshiki Watanabe, Takuya Ishii, Hiroki Tanaka, Mieko Shono
Introduction
The Center of New Surgical and Endoscopic Development for Exploratory Technology (NEXT) was founded in the National Cancer Center Hospital East 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 next-generation medical devices and technologies according to 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 next-generation medical devices and technologies according to clinical needs.
The Department for the Promotion of Medical Device Innovation is based in the NEXT Medical Device Innovation Center and promotes medical device innovation in NCCHE.
The Team and What We Do
The mission of the Department for the Promotion of Medical Device Innovation is “to change the world with the medical device innovation”. We undertake research and development on innovative medical devices and exploratory technology based on clinical needs in industry-academia-government and medical-engineering collaboration. Specifically, we target instruments, devices and digital systems used in/around the endoscopic and laparoscopic surgery fields. We promote their development in partnership with medical device businesses, "monozukuri" (manufacturing) companies, academia, local governments (especially Chiba Prefecture and Tokyo), and incubators. Furthermore, we support clinical trials in collaboration with the Office of Clinical Research Support, provide training for medical staff, and disseminate information as an advanced incubation facility.
Research Activities
The Department for the Promotion of Medical Device Innovation has initiated 43 new research and development collaborations with industry and academia partners. In particular, we have developed artificial intelligence (AI) applications for the medical field. A project on the medical applications of AI technology research and development, adopted by the Japan Agency for Medical Research and Development (AMED) as a funding support program, began this year. This project is a joint development with Asahi Surgical Robotics. This AI application will help surgeons determine the extent of cancer resection. We have promoted the project to develop a medical device that supports surgery to improve the efficiency and safety of surgery. We have also developed a rehabilitation app for breast cancer patients, a thin-diameter endoscope, AI apps for endoscopic diagnosis, apps for oxygen saturation imaging endoscopes, laparoscopic surgery training equipment, intubation assist device, surgical assist robots, and a glaucoma diagnosis support system. In recognition of these efforts in medical device development, our hospital was selected as one of the most active medical device development bases nationwide in AMED's Support Program this year.
Furthermore, we have promoted collaboration with startup companies in the development of medical devices with the aim of matching clinical needs and engineering seeds. To accelerate the matching and collaboration with venture companies, we held the "Medical Device Innovation in Kashiwanoha" symposium on October 22, as in as last year. In addition, an application for an additional indication for a medical device for which an investigator-initiated clinical trial was completed at our hospital in FY2022 was approved in March 2025. On a similar topic, in August 2024, Jmees Inc., which is a NCC-certified startup, obtained approval for a software as a medical device, which had been developed with our hospital.
Clinical Trials
1) The double-blind randomized control trial to relief the diStress from cheMotherapy-Induced peripheraL nEurophathy by magnetic field (SMILE) (Completed)
2) A double-blind randomized Control trial to Evaluate mitigation of CIPN by LImb-cooling Apparatus in breast cancer patients who undergo weekly paclitaxel (CECILIA) (Completed)
3) A phase Ib/II clinical study to investigate safety and efficacy of photo-immunotherapy (PIT) using ASP-1929 in patients with esophageal cancer for which complete cure cannot be expected with existing therapies (Ex-PIT) (Recruiting)
Education
We held the "NEXT seminar" 4 times in cooperation with National Cancer Center Hospital and Okayama University Hospital to develop human resources for creating innovative medical devices in our hospital. The "NEXT seminar" provided participants lectures on utilization of medical digital data for AI research and development, social implementation of AI for endoscopy and startups from academia. In our clinical field observation program, 180 individuals from 9 institutions have visited the operating room, endoscopy room, hospital ward including ICU and PCU, and rehabilitation room in our hospital to assess the clinical needs.
Future Prospects
As a new initiative for FY2024, we have focused on support for startups and international expansion through collaboration with external organizations under the support of AMED’s new support program. We will further accelerate this momentum, positioning ourselves as a top-tier medical device development hub in Japan. We will prioritize providing comprehensive support to startups with international ambitions, while also promoting collaboration with other hubs to lead medical device development across Japan. We will improve the system for clinical field observation programs, support obtaining POC through animal testing, and further promote cooperation with startup companies that possess innovative technological solutions. Furthermore, we will promote a program aimed at starting a startup company from NCC based on the clinical needs of our hospital in collaboration with science and technology academia and venture capitalists.
List of papers published in 2024
Journal
1. Minakata N, Ikematsu H, Kiyomi F, Inoue S, Akutagawa T, Watanabe T, Yano T, Shimoda R. Usefulness of virtual scale endoscope for early gastrointestinal lesions. DEN open, 5:e386, 2025
2. Ikematsu H, Takara Y, Nishihara K, Kano Y, Owaki Y, Okamoto R, Fujiwara T, Takamatsu T, Yamada M, Tomioka Y, Takeshita N, Inaba A, Sunakawa H, Nakajo K, Murano T, Kadota T, Shinmura K, Koga Y, Yano T. Possibility of determining high quantitative fecal occult blood on stool surface using hyperspectral imaging. Journal of gastroenterology, 60:77-85, 2025
3. Urabe A, Adachi M, Sakamoto N, Kojima M, Ishikawa S, Ishii G, Yano T, Sakashita S. Deep learning detected histological differences between invasive and non-invasive areas of early esophageal cancer. Cancer science, 116:824-834, 2025
4. Bando H, Naito Y, Yamada T, Fujisawa T, Imai M, Sakamoto Y, Saigusa Y, Yamamoto K, Tomioka Y, Takeshita N, Sunami K, Futamura M, Notake C, Aoki S, Okano K, Yoshino T. A prospective study comparing highly qualified Molecular Tumor Boards with AI-powered software as a medical device. International journal of clinical oncology, 30:172-179, 2025
5. Sato K, Takenaka S, Kitaguchi D, Zhao X, Yamada A, Ishikawa Y, Takeshita N, Takeshita N, Sakamoto S, Ichikawa T, Ito M. Objective surgical skill assessment based on automatic recognition of dissection and exposure times in robot-assisted radical prostatectomy. Langenbeck's archives of surgery, 410:39, 2025
6. Arakaki S, Takenaka S, Sasaki K, Kitaguchi D, Hasegawa H, Takeshita N, Takatsuki M, Ito M. Artificial Intelligence in Minimally Invasive Surgery: Current State and Future Challenges. JMA journal, 8:86-90, 2025
7. Nakajima K, Takenaka S, Kitaguchi D, Tanaka A, Ryu K, Takeshita N, Kinugasa Y, Ito M. Artificial intelligence assessment of tissue-dissection efficiency in laparoscopic colorectal surgery. Langenbeck's archives of surgery, 410:80, 2025
8. Kitaguchi D, Ito M. Correction to Dice Similarity Coefficient Formula. Diseases of the colon and rectum, 67:e304, 2024
9. Mitsui T, Sunakawa H, Yoda Y, Nishio M, Kondo S, Hamanaka J, Tokoro C, Nakajo K, Maeda S, Yano T, Hirasawa K. Novel gastric endoscopic submucosal dissection training model enhances the endoscopic submucosal dissection skills of trainees: a multicenter comparative study. Surgical endoscopy, 38:3088-3095, 2024
10. Shigaki T, Hasegawa H, Teramura K, Takeshita N, Ikeda K, Tsukada Y, Nishizawa Y, Sasaki T, Ito M. Development of a laparoscopic sigmoidectomy simulator: Sigmaster. Surgery today, 54:1272-1276, 2024
11. Kadota T, Abe S, Uedo N, Doyama H, Furue Y, Muto M, Nonaka S, Takamaru H, Murano T, Nakajo K, Tani Y, Okubo Y, Kawasaki A, Yoshida N, Watanabe A, Katada C, Tamaoki M, Yokoyama A, Furuya H, Ikeno T, Wakabayashi M, Yano T. Comparison of Effective Imaging Modalities for Detecting Gastric Neoplasms: A Randomized 3-Arm Phase II Trial. The American journal of gastroenterology, 119:2010-2018, 2024
12. Horita K, Hida K, Itatani Y, Fujita H, Hidaka Y, Yamamoto G, Ito M, Obama K. Real-time detection of active bleeding in laparoscopic colectomy using artificial intelligence. Surgical endoscopy, 38:3461-3469, 2024
13. Narihiro S, Kitaguchi D, Hasegawa H, Takeshita N, Ito M. Deep Learning-Based Real-Time Ureter Identification in Laparoscopic Colorectal Surgery. Diseases of the colon and rectum, 67:e1596-e1599, 2024
14. Yoshida M, Kitaguchi D, Takeshita N, Matsuzaki H, Ishikawa Y, Yura M, Akimoto T, Kinoshita T, Ito M. Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence: a proof-of-concept study. Langenbeck's archives of surgery, 409:213, 2024
15. Inaba A, Shinmura K, Matsuzaki H, Takeshita N, Wakabayashi M, Sunakawa H, Nakajo K, Murano T, Kadota T, Ikematsu H, Yano T. Smartphone application for artificial intelligence-based evaluation of stool state during bowel preparation before colonoscopy. Digestive endoscopy, 36:1338-1346, 2024
16. Nakajima K, Kitaguchi D, Takenaka S, Tanaka A, Ryu K, Takeshita N, Kinugasa Y, Ito M. Automated surgical skill assessment in colorectal surgery using a deep learning-based surgical phase recognition model. Surgical endoscopy, 38:6347-6355, 2024
17. Tanaka H, Koga Y, Sugahara M, Fuchigami H, Ishikawa A, Yamaguchi T, Banba A, Shinozaki T, Matsuura K, Hayashi R, Sakashita S, Yasunaga M, Yano T. Real-Time Fluorescence Monitoring System for Optimal Light Dosage in Cancer Photoimmunotherapy. Pharmaceuticals (Basel, Switzerland), 17:1246, 2024
18. Honda R, Kitaguchi D, Ishikawa Y, Kosugi N, Hayashi K, Hasegawa H, Takeshita N, Ito M. Deep learning-based surgical step recognition for laparoscopic right-sided colectomy. Langenbeck's archives of surgery, 409:309, 2024
19. Sunakawa T, Kitaguchi D, Kobayashi S, Aoki K, Kujiraoka M, Sasaki K, Azuma L, Yamada A, Kudo M, Sugimoto M, Hasegawa H, Takeshita N, Gotohda N, Ito M. Deep learning-based automatic bleeding recognition during liver resection in laparoscopic hepatectomy. Surgical endoscopy, 38:7656-7662, 2024