NCT05550974

Articulated Laparoscopic Instruments Clinical Study

Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,155 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

Detailed description

Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	Minimally Invasive Surgery	gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2022-09-22
• Last updated: 2022-10-03

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study