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