The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NCT Number: NCT07714629
Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. This prospective observational cohort study aims to compare robot-assisted and conventional manual CT-guided puncture techniques for pulmonary nodule ablation. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture accuracy, radiation exposure, and procedure-related complications. The results will provide evidence regarding the clinical effectiveness and safety of robot-assisted puncture in pulmonary nodule ablation.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Guangzhou, Guangdong, China
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety.
This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization.
The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses.
The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the procedure
Total number of needle adjustments required to achieve the planned puncture trajectory.
Time frame: During the procedure
Total number of CT scans performed during the puncture procedure.
Time frame: During the procedure
Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure.
Time frame: During the procedure
Puncture deviation was measured as the distance (mm) between the planned target point and the actual needle tip position after puncture.
Time frame: During the procedure
Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure.
Time frame: Within 48 hours after the procedure
Procedure-related complications were evaluated and graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system.
The First Affiliated Hospital of Guangzhou Medical University
Other
Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07484867
Lung Diseases, Lung Neoplasms
Zhengzhou, Henan, China
View Trial DetailsNCT05091437
Lung Diseases, Lung Neoplasms
CABA, Argentina
View Trial DetailsNCT03420885
Lung Diseases, Lung Neoplasms
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT02146131
Lung Diseases, Lung Neoplasms
Washington D.C., District of Columbia, United States
View Trial Details