Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study (NCT07055997) | Clinical Trial Compass
CompletedNot Applicable
Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study
China100 participantsStarted 2024-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
(â… ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (â…¡) 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; (â…¢) 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; (â…£) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention.
Exclusion Criteria:
(â… ) nodule location obstructed by the scapula, precluding needle access; (â…¡) proximity of the nodule to major blood vessels, defined as within 2 cm; (â…¢) requirement for localization of multiple pulmonary nodules.
What they're measuring
1
Localization Success Rate
Timeframe: Immediately after needle localization and before surgery
Trial details
NCT IDNCT07055997
SponsorThe First Affiliated Hospital of Guangzhou Medical University