Robot-Assisted Versus Free-Hand CT-Guided Flexible Guidewire Localization of Pulmonary Nodules

November 7, 2026 updated by: Peking University Third Hospital

A Prospective Randomized Controlled Study of Robot-Assisted Versus Conventional Free-Hand CT-Guided Preoperative Flexible Guidewire Localization of Pulmonary Nodules

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years.
  • A pulmonary nodule identified on preoperative high-resolution chest CT, with planned thoracoscopic wedge resection or segmentectomy.
  • Maximum target nodule diameter of 20 mm or less.
  • A pure ground-glass, part-solid (mixed ground-glass), or small solid nodule.
  • A nodule considered difficult to identify by intraoperative inspection or palpation and requiring preoperative CT-guided localization.
  • Ability to tolerate percutaneous pulmonary localization and subsequent video-assisted thoracoscopic surgery.
  • Voluntary participation and written informed consent from the participant or a legally authorized representative.

Exclusion Criteria:

  • Maximum target nodule diameter greater than 20 mm, or no need for preoperative localization in the investigator's judgment.
  • No safe puncture trajectory that avoids major vessels, the heart, mediastinum, severe bullous disease, or other important structures.
  • Severe pulmonary dysfunction that precludes percutaneous pulmonary puncture or thoracoscopic surgery.
  • Coagulation dysfunction or inability to interrupt anticoagulant or antiplatelet treatment according to clinical standards.
  • Clinically significant pneumothorax, pleural effusion, active infection, or another condition affecting safety assessment before localization.
  • Pregnancy or breastfeeding.
  • Inability to cooperate with positioning, breath-holding, or CT scanning.
  • Severe ipsilateral pleural adhesions, previous thoracic surgery, or previous radiotherapy considered to compromise localization safety.
  • Any other condition making participation unsuitable in the investigator's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot-Assisted CT-Guided Localization

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

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.

Other Names:
  • uInterv C550-A
Active Comparator: Conventional Free-Hand CT-Guided Localization

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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Dose-Length Product
Time Frame: During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment

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.
During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
First-Attempt Puncture Success Rate
Time Frame: During the localization procedure

Percentage of participants with satisfactory needle-tip placement on the first puncture attempt without subsequent needle adjustment.
During the localization procedure
Technical Localization Success Rate
Time Frame: From guidewire localization through completion of the subsequent thoracoscopic resection

Percentage of participants in whom flexible guidewire localization enables intraoperative identification and resection of the target pulmonary nodule during thoracoscopic surgery.
From guidewire localization through completion of the subsequent thoracoscopic resection
Localization Deviation
Time Frame: During localization, on the CT scan confirming final needle-tip position before guidewire deployment

Distance in millimeters between the planned target point and the actual needle-tip position, measured on CT after needle placement.
During localization, on the CT scan confirming final needle-tip position before guidewire deployment
Number of Needle Adjustments
Time Frame: During the localization procedure

Number of adjustments to needle position after the initial needle insertion during CT-guided localization.
During the localization procedure
Number of Pleural Punctures
Time Frame: During the localization procedure

Number of needle punctures through the pleura during CT-guided localization.
During the localization procedure
Localization Procedure Duration
Time Frame: During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan

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.
During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
Number of CT Acquisitions
Time Frame: During the localization procedure

Total number of CT acquisitions performed for localization, including the initial planning CT, scans during needle placement, and the final CT after guidewire deployment.
During the localization procedure
Pneumothorax Rate
Time Frame: From localization through 2 months after localization

Percentage of participants with localization-related pneumothorax, assessed on post-localization CT and during follow-up.
From localization through 2 months after localization
Intrapulmonary Hemorrhage Rate
Time Frame: From localization through 2 months after localization

Percentage of participants with localization-related intrapulmonary hemorrhage, assessed on post-localization CT and during follow-up.
From localization through 2 months after localization
Guidewire Dislodgement or Migration Rate
Time Frame: From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization

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.
From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fuxin Guo, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M20260645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings