Trials / Not Yet Recruiting

Not Yet RecruitingNCT07177924

Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 50 (estimated)

Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Monarch RAB with CBCT-guided ICG Dye Marking	Under general anesthesia, the Monarch RAB platform is used to navigate to the target bronchus. With CBCT confirmation, 0.25 ml of ICG (0.2 mg/ml) mixed with 0.25 ml iodinated contrast is injected within 1 cm of the nodule. The dye marking is identified intraoperatively with near-infrared light to guide VATS sublobectomy.

Timeline

Start date: 2025-10-10
Primary completion: 2026-04-30
Completion: 2026-05-30
First posted: 2025-09-17
Last updated: 2025-09-17

Source: ClinicalTrials.gov record NCT07177924. Inclusion in this directory is not an endorsement.