Feasibility of RUS Lung in MITS (HTL-001)

Hutom

Status: Not yet enrolling

Conditions: Lung Cancer

Treatments: Device: RUS Lung

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06952894

HTL-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

RUS Group

Experimental group

Description:

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

Treatment:

Device: RUS Lung