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NCT07177924Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
27 Aug 2025
Start date
10 Oct 2025
Primary completion date
30 Apr 2026
Lead sponsor
Peking University Cancer Hospital & Institute
Diseases
Lung cancer
NCT number
NCT07177924

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 10 Oct 2025 to the primary completion date, 30 Apr 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Coagulopathy or bleeding tendency
  • Allergy to ICG or iodinated contrast

Other

  • Contraindications to bronchoscopy/anesthesia
  • Implanted devices interfering with navigation
  • Pregnant/lactating women
  • Intraoperative findings not suitable for procedure

Who the study is looking for

  • Age 18-80 years
  • Clinically indicated sub-lobar resection
  • Tolerates general anesthesia
  • Single/multiple small nodules \<20 mm in peripheral lung field
  • Nodules difficult to locate intraoperatively by inspection/palpation

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.