Feasibility of RUS Lung in MITS

NCT ID: NCT06952894

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-08-11

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RUS Group

Patients undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung software.

Group Type: EXPERIMENTAL

RUS Lung

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals who were diagnosed with lung caner (tumor size≤3cm)
• Individuals aged 19 or older
• Individuals who who are able to undergo CT imaging according to the established protocol
• Individuals who have voluntarily given written consent to participate in this clinical trial

Exclusion Criteria

• Vulnerable subjects
• Individuals who who are not able to undergo CT imaging according to the established protocol
• Individuals who are expected to have severe adhesions
• Individuals who are unable to follow the study procedures and are deemed inappropriate for participation

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Ajou University School of Medicine

OTHER

Sponsor Role: collaborator

Hutom Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang Young Lee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HTL-001

Identifier Type: -

Identifier Source: org_study_id