NCT06952894

Feasibility of RUS Lung in MITS

Feasibility and Efficacy of Surgical Navigation 'RUS Lung' in Patients Undergoing Minimally Invasive Thoracic Surgery (MITS) Segmentectomy for Lung Cancer: a Multicenter Prospective Observational Study With a Propensity-score Matching Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hutom Corp · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This sponsor-initiated prospective observational study aims to demonstrate the feasibility and efficacy of RUS Lung Surgical Navigation System in patients undergoing minimally invasive thoracic surgery(MITS). The trial will enroll 36 patients who undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung. The study will be conducted across two medical centers." * Investigational Medical Device: RUS Lung (Endoscopic Imaging Treatment Planning Software) * Clinical Trial duration: 12 months from IRB approval * Target number of subjects: Total of 36 participants

Detailed description

Patients will be enrolled after being selected based on the inclusion and exclusion criteria and after obtaining informed consent. Video-assisted or robot-assisted thoracic surgery (VATS/RATS) will be performed using RUS Lung.Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 2 weeks after discharge. The operative outcomes including operative time, estimated blood loss, complication rates, and hospital length were compared with the historical control underwent VATS and RATS without using RUS Lung.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	RUS Lung	The RUS Lung is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the thoracic surgical environments, allowing for the visualization of tumor, bronchovascular structures and thoracic organs during the surgical planning process and the operation. RUS Lung utilizes preoperative CT images of the patients to segment tumor, organs, blood vessels, and bronchus and reconstructs them into a 3D model. Although there is no direct intervention on the patient, the surgeon uses RUS Lung as a surgical navigation tool to simulate the surgery before performing the actual procedure.

Timeline

• Start date: 2025-05-12
• Primary completion: 2025-05-28
• Completion: 2025-08-11
• First posted: 2025-05-01
• Last updated: 2025-09-03

Locations

1 site across 1 country: South Korea