Feasibility of RUS Lung in MITS (HTL-001)

August 26, 2025 updated by: Hutom Corp

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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