Feasibility of RUS Lung in MITS

NCT06952894 | Completed

• 1 other identifier: HTL-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

lung cancer; 3D model; 3 dimensional; segmentectomy; robot-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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. 1. CT turn-around time: the duration between uploading of preoperative CT and downloading the 3D model file 2. The stability of the RUS Lung system 3. The concordance rate of tumor location across CT, RUS Lung, and surgery

  The operative day (operative day ± 5 days)

Secondary Outcomes (1)

• 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

Study Arms (1)

RUS Group

EXPERIMENTAL

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

Device: RUS Lung

Interventions

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.

RUS Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutom Corp: lead
• Severance Hospital: collaborator
• Ajou University School of Medicine: collaborator

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chang Young Lee, M.D.,Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 1, 2025
• Study Start: May 12, 2025
• Primary Completion: May 28, 2025
• Study Completion: August 11, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

KR (1)