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Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study

NCT07055997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Lung Nodules
  • Lung Cancer (Diagnosis)
  • Robotic-Assisted Navigation System

Interventions

DEVICE

Robotic-assisted needle localization

Robot-assisted needle localization involves the use of a robotic system to assist with the percutaneous localization of pulmonary nodules under CT guidance. The robotic system provides real-time navigation and increased precision during needle placement, reducing the variability in positioning and improving the accuracy of localization. The system offers automatic adjustments to the needle's trajectory, minimizing the need for manual corrections, and potentially reducing the number of CT scans required. This method is designed to enhance the overall localization success rate and reduce complications associated with traditional manual techniques.

PROCEDURE

Manual needle localization

Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance without the assistance of robotic systems. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-12-31
Completion
2025-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07055997 on ClinicalTrials.gov