Clinical trial NCT06952894: Feasibility of RUS Lung in MITS
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
3D model
3 dimensional
segmentectomy
robot-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
Lead sponsor: Hutom Corp
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
name: Ajou University School of Medicine
First posted: 2025-05-01
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The concordance rate of tumor location across CT, RUS Lung, and surgery
timeFrame: The operative day (operative day ± 5 days)
Secondary outcomes:
measure: The degree of consistency between surgical planning using the RUS lung system and actual surgical findings.
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Chang Young Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: