Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Suspected or Confirmed) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Pulmonary Nodule Localization | — | UNRESOLVED | — |
| Small Pulmonary Nodules | — | UNRESOLVED | — |
| Video-assisted Thoracoscopic Surgery (VATS) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monarch RAB with CBCT-guided ICG Dye Marking | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy
- description
- All participants will undergo preoperative localization of small pulmonary nodules using indocyanine green (ICG) mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) guidance, performed by a single surgeon without prior RAB localization experience. Immediately after localization, patients will undergo video-assisted thoracoscopic surgery (VATS) sublobectomy (wedge resection or segmentectomy).
- interventionNames
- Procedure: Monarch RAB with CBCT-guided ICG Dye Marking
Primary outcomes (3)
- measure
- Success rate of localization procedure
- timeFrame
- Periprocedural( localization procedure)
- description
- Calculated as (number of successful localization procedures ÷ total localization procedures) × 100%. Success is defined as ICG dye successfully injected at planned target site as confirmed by CBCT. Unit of Measure: participants (%).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Contraindications to bronchoscopy/anesthesia * Coagulopathy or bleeding tendency * Implanted devices interfering with navigation * Allergy to ICG or iodinated contrast * Pregnant/lactating women * Intraoperative findings not suitable for procedure
References
Publications (0)
Data not yet available