Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity

February 3, 2026 updated by: Fujian Medical University Union Hospital

Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity: A Prospective Randomized Controlled Trial

  1. To compare the precision of robot-guided microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
  2. To evaluate the safety of robot-assisted microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
  3. Explore the application potential of robot navigation microwave ablation technology in the treatment of pulmonary nodules.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • 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

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

Description

Inclusion Criteria:

  1. Aged 18 to 85 years
  2. Nodules measuring 3-30mm with ground-glass opacities constituting ≥75% of the lesion
  3. Preoperative clinical evaluation confirming no hilar or mediastinal lymph node metastasis and no distant metastasis

  4. Patients diagnosed as stage IA primary peripheral lung cancer according to the UICC 8th TNM staging system, and with one of the following conditions:

    (i) cannot undergo surgical resection due to poor cardiopulmonary function or advanced age (ii) refusing or unwilling to undergo surgical resection (iii) with newly developed or residual pulmonary nodules after early-stage primary lung cancer surgery (iv) with unilateral lung disease who cannot undergo unilateral surgical resection (v)with multiple primary lung cancers unsuitable for surgical resection

  5. Preoperative ECOG physical status score is 0/1
  6. ASA score is I-III
  7. Patients voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

  1. Smoking cessation duration <2 weeks
  2. Lesions adjacent to pulmonary artery-vein main trunks
  3. Lesions near the hilum or adjacent to lobar bronchi
  4. Pregnancy or lactation status
  5. Severe mental disorders
  6. History of other malignancies within 5 years
  7. Unstable angina or myocardial infarction within 6 months with coronary angiography showing severe stenosis of major coronary branches
  8. Cerebral infarction or hemorrhage within 6 months
  9. Continuous systemic corticosteroid therapy within 1 month
  10. Patients or their authorized persons who do not wish to comply with the study protocol
  11. Patients with other investigator-assessed ineligibility for the trial

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Experimental group: Microwave ablation under robot navigation
Microwave ablation under robot navigation
Procedure: Robot
Microwave ablation guided by Robot or CT
Sham Comparator: Group B: CT-guided microwave ablation
Procedure: CT scan
CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of puncture
Time Frame: 24 month
The proportion of patients who are successfully punctured to the target pulmonary nodule on the first attempt of puncture among all patients; whether the puncture is successful is validated by CT scan.
24 month

Collaborators and Investigators

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

Sponsor

Fujian Medical University Union 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 (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • union TC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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