Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

This is a single-center, prospective, single-arm clinical study conducted at Beijing Cancer Hospital to evaluate the effectiveness, safety, and learning curve of preoperative indocyanine green (ICG) dye marking mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) for small pulmonary nodules that are difficult to locate during video-assisted thoracic surgery (VATS) sublobectomy. Eligible patients will undergo RAB localization immediately followed by VATS in the same operative session. The primary endpoints include the success rate of localization, effective localization, and VATS sublobar resection. Secondary endpoints include navigation success rate, operation times, reaching depth, complication rates, and health economic outcomes. The learning curve will be analyzed using the cumulative sum (CUSUM) method. A total of 50 patients will be enrolled and followed up for 14 days postoperatively.

NCT Number	NCT07177924
Lead Sponsor	Peking University Cancer Hospital & Institute
Conditions	Small Pulmonary Nodules, Pulmonary Nodule Localization, Lung Cancer (Suspected or Confirmed), Video-assisted Thoracoscopic Surgery (VATS)
Enrollment	50 participants
Start Date	2025-10-10
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-17