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Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS
NCT07177924 · Peking University Cancer Hospital & Institute · Updated 17 Sept 2025
- What is being tested
- Monarch RAB with CBCT-guided ICG Dye Marking
- For
- Small Pulmonary Nodules; Pulmonary Nodule Localization; Lung Cancer (Suspected or Confirmed); Video-assisted Thoracoscopic Surgery (VATS)
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 50 people. The full rules are on the registry page.
- Where
- Not stated
- When
- Starts or started 10 Oct 2025, ends 30 May 2026. Registered 17 Sept 2025.
- Results
- None posted yet.
In the researchers' words
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.