An interventional study of Robotic puncture navigation and positioning system and Free-Hand CT-Guided Flexible Guidewire Localization in Pulmonary Nodule, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Other
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Small pulmonary nodules can be difficult to identify during thoracoscopic surgery. CT-guided flexible guidewire localization helps surgeons locate these nodules before resection. This study compares robot-assisted and conventional free-hand localization at Peking University Third Hospital. Sixty adults who require preoperative localization will be randomly assigned to one of two groups, with 30 participants in each group. Both groups will use the same type of flexible guidewire localization needle. The primary objective is to compare radiation exposure measured by dose-length product. The study will also assess puncture performance, localization accuracy, procedure duration, CT scan count, and procedure-related complications.
This investigator-initiated, prospective, single-center, randomized, parallel-group study compares robot-assisted and conventional free-hand CT-guided flexible guidewire localization before thoracoscopic pulmonary nodule resection. Written informed consent is obtained before enrollment.
Participants undergo a localization difficulty assessment. A computer-generated sequence assigns participants in a 1:1 ratio within low- and high-difficulty strata using block randomization. Both groups use the same type of flexible guidewire localization needle. In the robot-assisted group, CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth, and inserts the needle with robotic trajectory guidance. Repeat CT confirms the needle position, and the guidewire is deployed after the planned target region has been reached. Post-localization CT assesses guidewire position and complications.
The procedure is open-label. The protocol specifies blinded assessment of post-localization CT images by two independent imaging physicians. Planned and actual puncture angles and depths, and the distance between the planned target and actual needle tip, are also recorded in the robot-assisted group. Conversion to free-hand localization is permitted when required for participant safety because of robotic system failure or failed registration, and the reason is recorded.
Continuous variables are summarized as means and standard deviations or medians and interquartile ranges, as appropriate. Between-group comparisons use the independent-samples t test or Mann-Whitney U test. Categorical variables are compared using the chi-square test or Fisher exact test.
Peking University Third Hospital is the lead sponsor of 755 studies on the registry; 276 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Clinically significant
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Participants undergo robot-assisted CT-guided flexible guidewire localization before thoracoscopic resection. The uInterv C550-A system is used for CT-based reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle.
Device: Robotic puncture navigation and positioning system
Participants undergo conventional free-hand CT-guided flexible guidewire localization before thoracoscopic resection. The physician selects the skin entry point and trajectory on CT images, inserts the localization needle under local anesthesia, and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle.
Procedure: Free-Hand CT-Guided Flexible Guidewire Localization
The uInterv C550-A robotic puncture navigation and positioning system is used for CT-guided preoperative flexible guidewire localization of pulmonary nodules. CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, skin entry point, puncture angle, and depth, and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before the flexible guidewire is deployed. A final CT scan assesses guidewire position and procedure-related complications. The same type of flexible guidewire localization needle is used in both groups.
Also known as: uInterv C550-A
Percutaneous placement of a flexible guidewire localization needle using conventional manual trajectory planning and CT guidance before thoracoscopic resection. The physician inserts and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment, followed by final CT assessment.
Total Dose-Length Product
Total dose-length product (DLP), measured in mGy·cm, summed across all localization-related CT acquisitions, including the initial planning CT, CT acquisitions during needle placement, and the final post-deployment CT.
Time frame: During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment
First-Attempt Puncture Success Rate
Percentage of participants with satisfactory needle-tip placement on the first puncture attempt without subsequent needle adjustment.
Time frame: During the localization procedure
Technical Localization Success Rate
Percentage of participants in whom flexible guidewire localization enables intraoperative identification and resection of the target pulmonary nodule during thoracoscopic surgery.
Time frame: From guidewire localization through completion of the subsequent thoracoscopic resection
Localization Deviation
Distance in millimeters between the planned target point and the actual needle-tip position, measured on CT after needle placement.
Time frame: During localization, on the CT scan confirming final needle-tip position before guidewire deployment
Number of Needle Adjustments
Number of adjustments to needle position after the initial needle insertion during CT-guided localization.
Time frame: During the localization procedure
Number of Pleural Punctures
Number of needle punctures through the pleura during CT-guided localization.
Time frame: During the localization procedure
Localization Procedure Duration
Elapsed time in minutes from the start of the first localization-related CT scan to completion of the final CT scan after flexible guidewire deployment.
Time frame: During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
Number of CT Acquisitions
Total number of CT acquisitions performed for localization, including the initial planning CT, scans during needle placement, and the final CT after guidewire deployment.
Time frame: During the localization procedure
Pneumothorax Rate
Percentage of participants with localization-related pneumothorax, assessed on post-localization CT and during follow-up.
Time frame: From localization through 2 months after localization
Intrapulmonary Hemorrhage Rate
Percentage of participants with localization-related intrapulmonary hemorrhage, assessed on post-localization CT and during follow-up.
Time frame: From localization through 2 months after localization
Guidewire Dislodgement or Migration Rate
Percentage of participants with dislodgement or migration of the localization guidewire after deployment, assessed on CT and during subsequent thoracoscopic surgery. Events are recorded during the 2-month safety follow-up; the guidewire is used for preoperative localization and is not intended to remain in place throughout follow-up.
Time frame: From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2027, 3 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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