Robot-Assisted Versus Manual Puncture for Pulmonary Nodule Ablation

NCT07714629 | Completed DMC

• 1 other identifier: ES-2024-129-02A
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Nodules

Keywords

Pulmonary Nodules; Robot-Assisted Puncture; CT-Guided Ablation; Robotic Navigation; Thermal Ablation; Cryoablation

Outcome Measures

Primary Outcomes (2)

• Number of Needle Adjustments

  Total number of needle adjustments required to achieve the planned puncture trajectory.

  During the procedure

• Number of Intraoperative CT Scans

  Total number of CT scans performed during the puncture procedure.

  During the procedure

Secondary Outcomes (4)

• Technical Success Rate

  During the procedure

• Puncture Deviation

  During the procedure

• Radiation Exposure

  During the procedure

• Procedure-Related Complications

  Within 48 hours after the procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: December 12, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 26, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)