Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
Not provided
Not provided
Not provided
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."
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUS Group | Experimental | Patients undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung software. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUS Lung | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The concordance rate of tumor location across CT, RUS Lung, and surgery | Overall feasibility of the RUS Lung system will be evaluated by 3 factors as below.
| The operative day (operative day ± 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of consistency between surgical planning using the RUS lung system and actual surgical findings. |
| From enrollment to the end of treatment at 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chang Young Lee, M.D.,Ph.D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 24, 2025 | |
| Reset | Jan 15, 2026 | |
| Release | Feb 3, 2026 | |
| Reset | Feb 19, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 24, 2025 | Jan 15, 2026 | |||
| Feb 3, 2026 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Feb 19, 2026 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |