Annual Report 2021

Next Medical Device Innovation Center

Masaru Konishi, Masaaki Ito, Tomonori Yano, Yusuke Yoda, Nobuyoshi Takeshita, Shinichiro Takahashi, Yusuke Hashimoto, Kenji Takashima, Hiro Hasegawa, Daichi Kitaguchi, Nobushige Takeshita, Shigehiro Kojima, Shin Takenaka, Kei Nakajima, Yoshito Shibusawa, Yumi Kinebuchi, Akihiro Hirao, Yuki Furusawa, Norihito Kosugi, Kazuyuki Hayashi, Hiroki Matsuzaki, Yuto Ishikawa, Shun Takahashi, Lee Younae, Atsushi Yamada, Mika Makari, Tomoko Ohe, Yuko Hitomi, Yukari Nagatsuma, Yuka Takahashi, Reria Sato, Megumi Kawakami, Mayumi Yamada, Miyuki Kondo, Machiko Kakihara, Ryuko Shimoda, Mariko Kikuta, Yoko Furuichi, Yoko Hatanaka, Emi Konno, Kazue Ando, Yoshiko Tomita, Ryotaro Okamoto, Yoshie Kasahara, Yuriko Harai, Kayoko Ogawa, Satoshi Narihiro, Shunsuke Someya, Daisuke Omori, Sachiko China, Atsuki Tanaka, Hiroko Honma, Kei Yanagisawa, Hajime Tachiki, Shota Wada, Saori Saito, Emi Takahashi, Miyo Takanashi, Yutaka Tomioka, Yasushi Nakamura, Nana Nagayama, Yusuke Kondo, Rina Azuma, Haruki Mitarai, Hibiki Kondo, Ryo Sekiguchi, Ibuki Watanabe, Norio Yamamoto, Mieko Shono, Yuka Mitsuke

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 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 and exploratory technology based on clinical needs in industry-academia-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, 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 NEXT Medical Device Innovation Center has undertaken 76 research and development collaborations with industry and academia partners. Especially, we have developed artificial intelligence (AI) applications for the medical field. Two active projects about 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 continuing since last year. In addition, we have promoted a project to develop a medical device that supports surgery and to create a database of surgical images of endoscopic surgery for the purpose of improving the efficiency and safety of surgery. We have also developed AI applications for endoscopic diagnosis, applications for oxygen saturation imaging endoscopes, surgical and endoscopic procedure training devices, and surgical support 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” (FY2019-2023) last year, and we have continued to participate in the program.

 Furthermore, we have promoted collaboration with venture companies in the development of medical devices with the idea of matching clinical needs and engineering seeds. To accelerate the matching and collaboration with venture companies, we held the “Medical Device Innovation in Kashiwanoha” symposiums on October 26 as well as last year.

Clinical trials

1) Cryoablation using the CryoBalloon Ablation System (CBAS) for superficial esophageal squamous cell carcinoma on or near the scar after endoscopic treatment: Efficacy and safety study.

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

3) A double-blind randomized Control trial to Evaluate mitigation of CIPN by LImb-cooling Apparatus in breast cancer patients who undergo weekly paclitaxel (CECILIA)

Education

 We held the “NEXT seminar” 10 times in order to develop human resources for creating innovative medical devices in our hospital. The “NEXT seminar” has given participants lectures about intellectual properties, the medical fee system in Japan, team building and entrepreneurship related to medical device development, and clinical developments related to in vitro diagnostics. In our clinical field observation program, 251 people from 11 institutions have visited the operating room and endoscopy room in our hospital in order to collect information on clinical needs.

Future Prospects

 We will promote the all-Japan medical devices development more and more as one of the most active bases of medical device development while working with other bases supported by AMED in the “Support Program on Collaborative Innovation Networks for Medical Device”. We will brush up the system for clinical field observation programs, support obtaining POC through animal tests, and further promote cooperation with venture companies that possess innovative technology solutions. In addition, we will start a program aimed at starting a venture company from NCC based on the clinical needs in our hospital in collaboration with venture capitalists.

List of papers published in 2021

Journal

1. Ikematsu H, Ishihara M, Okawa S, Minamide T, Mitsui T, Kuwata T, Ito M, Kinoshita T, Fujita T, Yano T, Omori T, Ozawa S, Murakoshi D, Irisawa K, Ochiai A. Photoacoustic imaging of fresh human surgically and endoscopically resected gastrointestinal specimens. DEN open, 2:e28, 2022

2. Kitaguchi D, Takeshita N, Hasegawa H, Ito M. Artificial intelligence-based computer vision in surgery: Recent advances and future perspectives. Annals of gastroenterological surgery, 6:29-36, 2022

3. Mori T, Ikeda K, Takeshita N, Teramura K, Ito M. Validation of a novel virtual reality simulation system with the focus on training for surgical dissection during laparoscopic sigmoid colectomy. BMC surgery, 22:12, 2022

4. Kitaguchi D, Takeshita N, Matsuzaki H, Hasegawa H, Igaki T, Oda T, Ito M. Deep learning-based automatic surgical step recognition in intraoperative videos for transanal total mesorectal excision. Surgical endoscopy, 36:1143-1151, 2022

5. Shinmura K, Yamamoto Y, Inaba A, Okumura K, Nishihara K, Kumahara K, Sunakawa H, Furue Y, Ito R, Sato D, Minamide T, Suyama M, Takashima K, Nakajo K, Murano T, Kadota T, Yoda Y, Hori K, Oono Y, Ikematsu H, Yano T. The safety and feasibility of endoscopic submucosal dissection using a flexible three-dimensional endoscope for early gastric cancer and superficial esophageal cancer: A prospective observational study. Journal of gastroenterology and hepatology, 37:749-757, 2022

6. Yamashita H, Kadota T, Minamide T, Sunakawa H, Sato D, Takashima K, Nakajo K, Murano T, Shinmura K, Yoda Y, Ikematsu H, Yano T. Efficacy and safety of second photodynamic therapy for local failure after salvage photodynamic therapy for esophageal cancer. Digestive endoscopy: official journal of the Japan Gastroenterological Endoscopy Society, 34:488-496, 2022

7. Yano T, Yoda Y, Nonaka S, Abe S, Kawata N, Yoshio T, Sasaki T, Tanaka S, Sasaki F, Maekita T, Kitano M, Matsumoto K, Isayama H, Ono H. Pivotal trial of a biodegradable stent for patients with refractory benign esophageal stricture. Esophagus: official journal of the Japan Esophageal Society, 19:516-524, 2022

8. Takashima K, Koga Y, Anzai T, Migita K, Yamaguchi T, Ishikawa A, Sakashita S, Yasunaga M, Yano T. Evaluation of Fluorescence Intensity and Antitumor Effect Using Real-Time Imaging in Photoimmunotherapy. Pharmaceuticals (Basel, Switzerland), 15:2022

9. Igaki T, Kitaguchi D, Kojima S, Hasegawa H, Takeshita N, Mori K, Kinugasa Y, Ito M. Artificial Intelligence-Based Total Mesorectal Excision Plane Navigation in Laparoscopic Colorectal Surgery. Diseases of the colon and rectum, 65:e329-e333, 2022

10. Kitaguchi D, Watanabe Y, Madani A, Hashimoto DA, Meireles OR, Takeshita N, Mori K, Ito M. Artificial Intelligence for Computer Vision in Surgery: A Call for Developing Reporting Guidelines. Annals of surgery, 275:e609-e611, 2022

11. Nishizawa Y, Nishigori H, Tsukada Y, Sasaki T, Tsukamoto S, Kanemitsu Y, Nakano D, Yamaguchi T, Otsuka K, Nakamura T, Shiomi A, Iwasaki N, Tamura H, Wakabayashi M, Nomura S, Ito M. A multicentre confirmatory single-arm trial of the safety and efficacy of a transanal drain for prevention of anastomotic leakage after surgery for rectal cancer. Colorectal disease: the official journal of the Association of Coloproctology of Great Britain and Ireland, 23:3196-3204, 2021

12. Sunakawa H, Yoda Y, Takeshita N, Hasegawa H, Takashima K, Kadota T, Fujita T, Akimoto T, Fujii S, Yano T. Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study. BMC gastroenterology, 21:234, 2021

13. Kitaguchi D, Takeshita N, Matsuzaki H, Igaki T, Hasegawa H, Ito M. Development and Validation of a 3-Dimensional Convolutional Neural Network for Automatic Surgical Skill Assessment Based on Spatiotemporal Video Analysis. JAMA network open, 4:e2120786, 2021

14. Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. Journal of clinical medicine, 10:2021

15. Minamide T, Sashiyama H, Muramatsu Y, Yada T, Matsumura T, Takeda S, Suzuki T, Kakimoto T, Yano T, Yoshii K, Arai M, Uemura N, Yamaguchi T, Ikematsu H. Second-generation narrow-band imaging to detect colorectal adenomas: A prospective study including community hospitals. Journal of gastroenterology and hepatology, 36:3084-3091, 2021

16. Sato D, Takamatsu T, Umezawa M, Kitagawa Y, Maeda K, Hosokawa N, Okubo K, Kamimura M, Kadota T, Akimoto T, Kinoshita T, Yano T, Kuwata T, Ikematsu H, Takemura H, Yokota H, Soga K. Author Correction: Distinction of surgically resected gastrointestinal stromal tumor by near-infrared hyperspectral imaging. Scientific reports, 11:19030, 2021

17. Hori K, Ikematsu H, Yamamoto Y, Matsuzaki H, Takeshita N, Shinmura K, Yoda Y, Kiuchi T, Takemoto S, Yokota H, Yano T. Detecting colon polyps in endoscopic images using artificial intelligence constructed with automated collection of annotated images from an endoscopy reporting system. Digestive endoscopy: official journal of the Japan Gastroenterological Endoscopy Society, 2021

18. Nakajo K, Yoda Y, Kadota T, Murano T, Shinmura K, Ikematsu H, Akimoto T, Yano T. Radial incision and cutting for dilation before endoscopic submucosal dissection in patients with esophageal cancer on the distal side of severe benign esophageal strictures. Diseases of the esophagus: official journal of the International Society for Diseases of the Esophagus, 34:2021

19. Kitaguchi D, Takeshita N, Matsuzaki H, Hasegawa H, Honda R, Teramura K, Oda T, Ito M. Computer-assisted real-time automatic prostate segmentation during TaTME: a single-center feasibility study. Surgical endoscopy, 35:2493-2499, 2021

20. Enomoto H, Nishizawa Y, Inamori K, Hasegawa H, Ikeda K, Tsukada Y, Sasaki T, Ito M. Sacral neuromodulation for the prevention of a permanent stoma in patients with severe defecation disorder following intersphincteric resection. Surgery today, 51:1379-1386, 2021