Annual Report 2023

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, Yuta Suzuki, Shin Takenaka, Xue Zhao, Norihito Kosugi, Kazuyuki Hayashi, Younae Lee, Yuto Ishikawa, Atsushi Yamada, Satoshi Kaneta, Masami Namihira, Kenji Ohtsuka, Rina Azuma, Haruki Mitarai, Wang Yifan, Shogo Hamano, Yuki Sekiguchi, Atsuki Tanaka, Koichiro Yoshida, Mayumi Yamada, Saki Minamimatsu, Yoshiko Tomita, Tomoko Ohe, Yuko Hitomi, Yukari Nagatsuma, Yuka Takahashi, Yoshie Kasahara, Hiroko Homma, Kayoko Ogawa, Ryuko Shimoda, Yoko Furuichi, Kazue Ando, Nana Nagayama, Haruya Takasaki, Sachiko China, Kei Matsumoto, Yutaka Tomioka, Yasushi Nakamura, Yasuyuki Yoshida, Ryo Sekiguchi, Norio Yamamoto, Kayo Suzuki, Megumi Kawakami, Yumi Denda, Kosei Hamagashira, Yoshihiro Haruki, Yuki Furusawa, 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. Especially, 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 have been ongoing since FY2019. 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 AI applications for endoscopic diagnosis, applications for oxygen saturation imaging endoscopes, laparoscopic surgery training equipment, intubation assist device, and surgical assist robots. In recognition of these efforts in medical device development, our hospital was adopted as one of the 14 medical device development bases nationwide in AMED's "Support Program on Collaborative Innovation Networks for Medical Device" continuously since FY2019.

 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 25, as in last year. In addition, an application for approval of an additional indication for a medical device for which an investigator-initiated clinical trial was completed at our hospital last year was submitted in August. On a similar topic, Jmees Inc., an NCC-certified startup, applied for approval of software as a medical device in July, which had been developed with our hospital, and in November we initiated the clinical use of “ANSUR surgical unit,” which had been developed by Asahi Surgical Robotics Co., Ltd. with our hospital and was approved by the MHLW in February 2023.

Clinical Trials

1) The double-blind randomized control trial to relief the diStress from cheMotherapy-Induced peripheraL nEurophathy by magnetic field (SMILE) (Recruiting)

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) (Recruiting)

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" 8 times in cooperation with National Cancer Center Hospital to develop human resources for creating innovative medical devices in our hospital. The "NEXT seminar" provided participants lectures on entrepreneurship, intellectual properties, public health insurance, quality management system, and startup. In our clinical field observation program, 307 individuals from 19 institutions have visited the operating room, endoscopy room, hospital ward, and department of radiology in our hospital to assess the clinical needs.

Future Prospects

 We will continue to promote all-Japan medical device development as one of the most active bases of medical device development, although the support by AMED in the "Support Program on Collaborative Innovation Networks for Medical Device" has completed in FY2023. We will improve the system for clinical field observation programs, support obtaining POC through animal tests, and further promote cooperation with startup companies that possess innovative technology 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 2023

Journal

1. Sunakawa H, Yoda Y, Nonaka S, Suzuki H, Abe S, Ishiguro Y, Ikeno T, Wakabayashi M, Sato A, Nakajo K, Kadota T, Yano T. Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on the post-endoscopic resection scar. A CRYO-SCAR study (EPOC1902). Gastrointestinal endoscopy, S0016-5107(24)00134-2, 2024

2. Fujita T, Sato K, Fujiwara N, Kajiyama D, Shigeno T, Daiko H. A novel imaging technology to assess tissue oxygen saturation and its correlation with indocyanine green in the gastric conduit during thoracic esophagectomy. Surgery, 175:360-367, 2024

3. Fujita T, Shigeno T, Kajiyama D, Sato K, Fujiwara N, Daiko H. A novel device to assess the oxygen saturation and congestion status of the gastric conduit in thoracic esophagectomy. BMC surgery, 24:17, 2024

4. Komatsu M, Kitaguchi D, Yura M, Takeshita N, Yoshida M, Yamaguchi M, Kondo H, Kinoshita T, Ito M. Automatic surgical phase recognition-based skill assessment in laparoscopic distal gastrectomy using multicenter videos. Gastric cancer, 27:187-196, 2024

5. Ryu K, Kitaguchi D, Nakajima K, Ishikawa Y, Harai Y, Yamada A, Lee Y, Hayashi K, Kosugi N, Hasegawa H, Takeshita N, Kinugasa Y, Ito M. Deep learning-based vessel automatic recognition for laparoscopic right hemicolectomy. Surgical endoscopy, 38:171-178, 2024

6. Une N, Kobayashi S, Kitaguchi D, Sunakawa T, Sasaki K, Ogane T, Hayashi K, Kosugi N, Kudo M, Sugimoto M, Hasegawa H, Takeshita N, Gotohda N, Ito M. Intraoperative artificial intelligence system identifying liver vessels in laparoscopic liver resection: a retrospective experimental study. Surgical endoscopy, 38:1088-1095, 2024

7. Koganemaru S, Fuchigami H, Yamashita H, Morizono C, Sunakawa H, Kawazoe A, Nakamura Y, Kuboki Y, Shitara K, Yano T, Doi T, Yasunaga M. Quantitative Analysis of the Concentration of Trifluridine in Tumor Hypoxic Regions Using a Novel Platform Combining Functional Endoscopy and Mass Spectrometry. Clinical pharmacology and therapeutics, 115:62-70, 2024

8. Takamatsu T, Tanaka H, Yano T. Near-Infrared Fluorescence Imaging Sensor with Laser Diffuser for Visualizing Photoimmunotherapy Effects under Endoscopy. Sensors (Basel, Switzerland), 24:1487, 2024

9. Furue Y, Yoda Y, Hori K, Nakajo K, Kadota T, Murano T, Shinmura K, Ikematsu H, Yano T. Outcomes of repeated endoscopic submucosal dissection for superficial Esophageal squamous cell carcinoma on endoscopic resection scar. Diseases of the esophagus, doae018, 2024

10. Minakata N, Sakashita S, Wakabayashi M, Nakamura Y, Sunakawa H, Yoda Y, Ishii G, Yano T. Immunohistochemistry and oxygen saturation endoscopic imaging reveal hypoxia in submucosal invasive esophageal squamous cell carcinoma. Cancer medicine, 12:15809-15819, 2023

11. Nakajo K, Ninomiya Y, Kondo H, Takeshita N, Uchida E, Aoyama N, Inaba A, Ikematsu H, Shinozaki T, Matsuura K, Hayashi R, Akimoto T, Yano T. Anatomical classification of pharyngeal and laryngeal endoscopic images using artificial intelligence. Head & neck, 45:1549-1557, 2023

12. Mitsui T, Mori A, Takamatsu T, Kadota T, Sato K, Fukushima R, Okubo K, Umezawa M, Takemura H, Yokota H, Kuwata T, Kinoshita T, Ikematsu H, Yano T, Maeda S, Soga K. Evaluating the identification of the extent of gastric cancer by over-1000 nm near-infrared hyperspectral imaging using surgical specimens. Journal of biomedical optics, 28:086001, 2023

13. Sasaki S, Kitaguchi D, Takenaka S, Nakajima K, Sasaki K, Ogane T, Takeshita N, Gotohda N, Ito M. Machine learning-based Automatic Evaluation of Tissue Handling Skills in Laparoscopic Colorectal Surgery: A Retrospective Experimental Study. Annals of surgery, 278:e250-e255, 2023

14. Kojima S, Kitaguchi D, Igaki T, Nakajima K, Ishikawa Y, Harai Y, Yamada A, Lee Y, Hayashi K, Kosugi N, Hasegawa H, Ito M. Deep-learning-based semantic segmentation of autonomic nerves from laparoscopic images of colorectal surgery: an experimental pilot study. International journal of surgery (London, England), 109:813-820, 2023

15. Hasegawa H, Takeshita N, Hyon W, Hyon SH, Ito M. Novel external reinforcement device for gastrointestinal anastomosis in an experimental study. BMC surgery, 23:121, 2023

16. Igaki T, Kitaguchi D, Matsuzaki H, Nakajima K, Kojima S, Hasegawa H, Takeshita N, Kinugasa Y, Ito M. Automatic Surgical Skill Assessment System Based on Concordance of Standardized Surgical Field Development Using Artificial Intelligence. JAMA surgery, 158:e231131, 2023

17. Kitaguchi D, Harai Y, Kosugi N, Hayashi K, Kojima S, Ishikawa Y, Yamada A, Hasegawa H, Takeshita N, Ito M. Artificial intelligence for the recognition of key anatomical structures in laparoscopic colorectal surgery. The British journal of surgery, 110:1355-1358, 2023

18. Takemoto S, Hori K, Yoshimasa S, Nishimura M, Nakajo K, Inaba A, Sasabe M, Aoyama N, Watanabe T, Minakata N, Ikematsu H, Yokota H, Yano T. Computer-aided demarcation of early gastric cancer: a pilot comparative study with endoscopists. Journal of gastroenterology, 58:741-750, 2023

19. Yano T. Impact and potential use of disposable single-use endoscopes. Digestive endoscopy, 35:866-868, 2023

20. Mitsui T, Sunakawa H, Takayama S, Murano T, Shinmura K, Ikematsu H, Yano T. Development of a novel colorectal endoscopic submucosal dissection training model. Endoscopy, 55:E808-E810, 2023

21. Kubo E, Harada M, Ishizuka K, Umetsu K, Inoue Y, Kosugi K, Miura T. Letter to the Editor: Three Cases of Pain Treatment in Cancer Patients Using an Alternating Magnetic Field Therapy Device. Journal of palliative medicine, 26:1444-1445, 2023

22. Komai Y, Nakajima K, Saito K, Tomioka Y, Masuda H, Ogawa A, Yonese J, Kobayashi E, Ito M. Development of a New Two-Arm Transurethral Surgical System for En Bloc Resection of Bladder Tumor: A Preclinical Study. Journal of endourology, 37:165-170, 2023

23. Takeshita N, Sakamoto S, Kitaguchi D, Takeshita N, Yajima S, Koike T, Ishikawa Y, Matsuzaki H, Mori K, Masuda H, Ichikawa T, Ito M. Deep Learning-Based Seminal Vesicle and Vas Deferens Recognition in the Posterior Approach of Robot-Assisted Radical Prostatectomy. Urology, 173:98-103, 2023

24. Kitaguchi D, Teramura K, Matsuzaki H, Hasegawa H, Takeshita N, Ito M. Automatic purse-string suture skill assessment in transanal total mesorectal excision using deep learning-based video analysis. BJS open, 7:zrac176, 2023

25. Hasegawa H, Takeshita N, Ito M. Computer Aided Surgery in the Gastrointestinal Field. Journal of Japan Society of Computer Aided Surgery, 25:56-60, 2023