Lung CancerHTL-001NCT06952894
Feasibility of RUS Lung in MITS
A study testing RUS Lung in people with Lung Cancer, run by Hutom Corp at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- RUS Lung
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2025to 11 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- RUS Lung
- Keywords
- lung cancer, 3D model, 3 dimensional, segmentectomy, robot-assisted thoracoscopic surgery, video-assisted thoracoscopic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUS LungDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RUS Group | Experimental | Patients undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung software. Receives: Device: RUS Lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- 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
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 May 2025
- Primary completion28 May 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutom Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Ajou University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Chang Young Lee, M.D.,Ph.D., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952894
- Sponsor's protocol ID
- HTL-001
- Acronym
- HTL-001
- Status last verified
- Aug 2025
- First submitted
- 9 Apr 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06952894
- Acronym / sponsor ID
- HTL-001 / HTL-001
- Conditions
- Lung Cancer
- Keywords
- lung cancer, 3D model, 3 dimensional, segmentectomy, robot-assisted thoracoscopic surgery, video-assisted thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hutom CorpIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Ajou University School of Medicine
- Study start
- 12 May 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RUS Group | Experimental | Device: RUS LungPatients undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung software. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUS LungThe 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. | Device | RUS Group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Young Lee, M.D.,Ph.D. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUS Lung in people with Lung Cancer, run by Hutom Corp at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concordance rate of tumor location across CT, RUS Lung, and surgery (time frame: The operative day (operative day ± 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.