Robot-Assisted Versus Manual Puncture for Pulmonary Nodule Ablation

July 15, 2026 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with peripheral pulmonary nodules who underwent CT-guided thermal ablation at the First Affiliated Hospital of Guangzhou Medical University. Participants received either robot-assisted or conventional manual puncture according to routine clinical practice.

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation.
  • Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice.
  • Written informed consent provided.

Exclusion Criteria:

  • Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures.
  • Previous thoracic surgery or local treatment affecting puncture planning.
  • Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation.
  • Pregnancy.
  • Inability or unwillingness to provide informed consent.

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

Cohorts and Interventions

Group / Cohort
Robot-Assisted Puncture
Patients undergoing CT-guided pulmonary nodule ablation using the TH-S1 robotic navigation system.
Manual Puncture
Patients undergoing conventional manual CT-guided pulmonary nodule ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Needle Adjustments
Time Frame: During the procedure
Total number of needle adjustments required to achieve the planned puncture trajectory.
During the procedure
Number of Intraoperative CT Scans
Time Frame: During the procedure
Total number of CT scans performed during the puncture procedure.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success Rate
Time Frame: During the procedure
Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure.
During the procedure
Puncture Deviation
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.
During the procedure
Radiation Exposure
Time Frame: During the procedure
Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure.
During the procedure
Procedure-Related Complications
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.
Within 48 hours after the procedure

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

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)

December 12, 2024

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

June 26, 2025

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2024-129-02A

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.

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