Feasibility of RUS Lung in MITS (HTL-001)

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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: RUS Lung

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RUS Group; Patients undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung software.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; CT turn-around time: the duration between uploading of preoperative CT and downloading the 3D model file; The stability of the RUS Lung system; The concordance rate of tumor location across CT, RUS Lung, and surgery	The operative day (operative day ± 5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of consistency between surgical planning using the RUS lung system and actual surgical findings.	The consistency of surgical planning (using CT and RUS, respectively) and operative findings; Surgical outcomes (operative time, estimated blood loss, hospital length, and complication rates); User convenience	From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

• Sponsor: Hutom Corp
• Collaborators: Ajou University School of Medicine; Severance Hospital
• Investigators: Principal Investigator: Chang Young Lee, M.D.,Ph.D., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): August 11, 2025

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; segmentectomy; video-assisted thoracoscopic surgery; 3D model; robot-assisted thoracoscopic surgery; 3 dimensional
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HTL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No