Clinical trial · Interventional
Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study
The Effectiveness of Robotic-assisted Navigation System for Preoperative Lung Nodule Localization: a Prospective, Single-center, Non-inferiority Clinical Study
NCT07055997CI-TRIAL-00091944completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates.
Conditions
Conditions (3)
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 (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Nodules | — | UNRESOLVED | — |
| Robotic-Assisted Navigation System | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manual needle localization | Procedure | — | UNRESOLVED |
| Robotic-assisted needle localization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Freehand group
- description
- Manual CT-guided percutaneous needle localization of pulmonary nodules
- interventionNames
- Procedure: Manual needle localization
- type
- EXPERIMENTAL
- label
- Robotic group
- description
- Robotic-assisted CT-guided percutaneous needle localization of pulmonary nodules
- interventionNames
- Device: Robotic-assisted needle localization
Primary outcomes (1)
- measure
- Localization Success Rate
- timeFrame
- Immediately after needle localization and before surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: (Ⅰ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (Ⅱ) the presence of pure ground-glass opacity (GGO) or mixed GGO (solid to tumor ratio \< 0.5) on CT with clinical or radiological suspicion of malignancy; (Ⅲ) patient with a peripheral nodule, located in the outer third of the lung parenchyma, with its edge situated at least 5 mm away from the pleural surface; (Ⅳ) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention. Exclusion Criteria: (Ⅰ) nodule location obstructed by the scapula, precluding needle access; (Ⅱ) proximity of the nodule to major blood vessels, defined as within 2 cm; (Ⅲ) requirement for localization of multiple pulmonary nodules.
References
Publications (0)
Data not yet available
No reference posted for this study.