NCT05039333

Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation

Prospective Observational Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation, Endoscopic Imaging Treatment Planning Software, in Gastric Cancer Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Hutom Corp · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.

Detailed description

* Obtain consent from a patient who is diagnosed with gastric cancer and is scheduled for robotic surgery. * Take an abdominal CT before gastric cancer surgery according to the prescribed protocol. * Upload patient information and CT information before surgery to RUS™, an endoscopic treatment image planning software, to build a 3D modeling navigation system for a patient-customized surgical environment. (Measure the time (in days) from the time the CT is uploaded to the time when the RUS™ software can be operated.) * Before surgery, use the RUS™ navigation system to check the patient's relief and anatomical structure, mark the planned trocar insertion site, and obtain distance information from the umbilical trocar. ⑤ After general anesthesia on the day of surgery, mark the Landmark 25 area on the abdominal wall using a surgical marking pen. In addition, the abdominal wall surface scan is performed using a laser 3D scanner. ⑥ After the undulations are formed, the deformed abdominal wall surface is scanned with a laser 3D scanner. ⑦ Evaluate the degree of agreement between the patient's actual relief state measured in steps ⑤ and ⑥ and the patient's relief model predicted through the relief prediction model in RUS™. ⑧ When the trocar is inserted through an anatomical landmark after the actual patient's relief, compare the position information of the trocar with the trocar position information of the RUS™ measured in advance in step ④ to check its accuracy. ⑨ Check whether the blood vessels that must be checked during the total gastrectomy procedure (left omentary artery, left umbilical vein, superior omentum, superior vena cava, left gastric artery, superior artery, and left hepatic branching left hepatic artery) are presented in the RUS™ blood vessel segmentation model. ⑩ Among the vessels mentioned in step ⑨, for the vessels suggested by RUS™ for vessels (left gastric artery, superior artery, left gastric vein, and gastric colonic vein), check the anatomical positional relationship and measure branch points during actual surgery. Check the accuracy of matching with the anatomical location information and branching distance of the segmentation model.

Conditions

• Surgery
• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	RUS(TM) software : surgical navigation	This clinical trial is a sponsor-led clinical trial, and it is intended to confirm that RUS™, a surgical navigation system certified for level 2 endoscopic imaging treatment planning software, can be applied to real people as a clinical study by using preoperative CT and to confirm the safety of surgery. In addition, the secondary research objective was to examine the accuracy of the intra-abdominal surgical navigation system provided by RUS™ including: 1) the accuracy of the undulation prediction model, 2) the accuracy of the trocar insertion position, 3) the adequacy of 3D reconstruction of the main vessels, 4) the accuracy of the major vessel branching distances, 5) the intraoperative bleeding volume and operating time, and 6) the postoperative hospitalization period and complication rate were compared with the past control group.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-12-24
• Completion: 2022-06-23
• First posted: 2021-09-09
• Last updated: 2021-09-09

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study