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NCT Number: NCT06952894

Feasibility of RUS Lung in MITS

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

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The concordance rate of tumor location across CT, RUS Lung, and surgery

    Time frame: The operative day (operative day ± 5 days)

    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

Secondary outcomes

  1. The degree of consistency between surgical planning using the RUS lung system and actual surgical findings.

    Time frame: From enrollment to the end of treatment at 2 weeks

    • 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

Sponsors and collaborators

Lead sponsor

Hutom Corp

Industry

Collaborators

  • Ajou University School of Medicine
  • Severance Hospital

Registry information

Official study title

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

Acronym: HTL-001

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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