MedInTech Co., Ltd. (CEO: Chi-Won Lee) announced that it is recruiting participants for a clinical trial of an upper gastrointestinal endoscope jointly developed with Seoul National University Hospital, Seoul National University, the Korea Electrotechnology Research Institute (KERI), and Korea University of Technology and Education (KOREATECH).
This clinical trial will be conducted through a public platform operated by the Korea National Institute of Clinical Trial Support (KoNECT), with participant recruitment beginning on Thursday, July 4.
The trial targets healthy adults aged 19 to 70 who wish to undergo an upper gastrointestinal endoscopy for screening purposes. The medical device clinical trial (KS-ENDO) will compare overall performance—including participant satisfaction, endoscopic image quality, and ease of operation—between the domestically developed gastroscope and conventional upper GI endoscopes.
The investigational medical devices include the smart flexible electronic endoscope scope (MEDIUFES Video Gastroscope MGS-400/410) and the endoscopic light source system (MEDIUFES Video System ME-400) developed by MedInTech, both of which have received approval from Korea’s Ministry of Food and Drug Safety (MFDS). The trial will enroll a total of 170 participants and will be conducted at the Division of Gastroenterology, Seoul National University Hospital.
MedInTech’s gastroscope features high-resolution image quality (FHD) and excellent bending performance, along with a lightweight handle and improved directional control compared to conventional endoscopes. In addition, by moving away from traditional mechanical operation, the device is designed to be compatible with various procedure-assisting AI software, lesion detection software, and blind-spot prevention software, which is expected to significantly reduce misdiagnosis rates in the future.
KoNECT has established a dedicated KS-ENDO clinical trial page on the Korean Clinical Trial Participation Portal, supporting all procedures from application to satisfaction surveys. Members of the public who wish to participate or learn more can apply through the portal.
Applicants will first complete a screening questionnaire sent via KakaoTalk notification message. Based on the responses, eligible candidates will be selected and contacted by the research team to schedule a visit. The clinical trial will proceed in the following order: in-person screening, participation confirmation, subject registration, and sedated upper GI endoscopy. Satisfaction surveys will be conducted via KakaoTalk 4 hours after the procedure and again 7 days later.
For inquiries related to participation, applicants may receive assistance from professional counselors at the KoNECT Participant Support Center.
Reporter: Choong-gi Ahn (newnew9@joongang.co.kr)
View the original article
중앙일보 - https://www.joongang.co.kr/article/25261470
한국경제 - https://www.hankyung.com/article/202407054945O
서울신문 - https://www.seoul.co.kr/news/economy/2024/07/09/20240709500115?wlog_tag3=naver
MedInTech Co., Ltd. (CEO: Chi-Won Lee) announced that it is recruiting participants for a clinical trial of an upper gastrointestinal endoscope jointly developed with Seoul National University Hospital, Seoul National University, the Korea Electrotechnology Research Institute (KERI), and Korea University of Technology and Education (KOREATECH).
This clinical trial will be conducted through a public platform operated by the Korea National Institute of Clinical Trial Support (KoNECT), with participant recruitment beginning on Thursday, July 4.
The trial targets healthy adults aged 19 to 70 who wish to undergo an upper gastrointestinal endoscopy for screening purposes. The medical device clinical trial (KS-ENDO) will compare overall performance—including participant satisfaction, endoscopic image quality, and ease of operation—between the domestically developed gastroscope and conventional upper GI endoscopes.
The investigational medical devices include the smart flexible electronic endoscope scope (MEDIUFES Video Gastroscope MGS-400/410) and the endoscopic light source system (MEDIUFES Video System ME-400) developed by MedInTech, both of which have received approval from Korea’s Ministry of Food and Drug Safety (MFDS). The trial will enroll a total of 170 participants and will be conducted at the Division of Gastroenterology, Seoul National University Hospital.
MedInTech’s gastroscope features high-resolution image quality (FHD) and excellent bending performance, along with a lightweight handle and improved directional control compared to conventional endoscopes. In addition, by moving away from traditional mechanical operation, the device is designed to be compatible with various procedure-assisting AI software, lesion detection software, and blind-spot prevention software, which is expected to significantly reduce misdiagnosis rates in the future.
KoNECT has established a dedicated KS-ENDO clinical trial page on the Korean Clinical Trial Participation Portal, supporting all procedures from application to satisfaction surveys. Members of the public who wish to participate or learn more can apply through the portal.
Applicants will first complete a screening questionnaire sent via KakaoTalk notification message. Based on the responses, eligible candidates will be selected and contacted by the research team to schedule a visit. The clinical trial will proceed in the following order: in-person screening, participation confirmation, subject registration, and sedated upper GI endoscopy. Satisfaction surveys will be conducted via KakaoTalk 4 hours after the procedure and again 7 days later.
For inquiries related to participation, applicants may receive assistance from professional counselors at the KoNECT Participant Support Center.
Reporter: Choong-gi Ahn (newnew9@joongang.co.kr)
View the original article
중앙일보 - https://www.joongang.co.kr/article/25261470
한국경제 - https://www.hankyung.com/article/202407054945O
서울신문 - https://www.seoul.co.kr/news/economy/2024/07/09/20240709500115?wlog_tag3=naver