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Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

NCT07177924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-17

No results posted yet for this study

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

  • Small Pulmonary Nodules
  • Pulmonary Nodule Localization
  • Lung Cancer (Suspected or Confirmed)
  • Video-assisted Thoracoscopic Surgery (VATS)

Interventions

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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Shaohua Ma · Peking University Cancer Hospital & Institute, Beijing 100142, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-04-30
Completion
2026-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177924 on ClinicalTrials.gov