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

NCT07389889 | Not Yet Recruiting

• 1 other identifier: union TC1
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Nodules; Ground-glass Opacity

Keywords

ggo

Outcome Measures

Primary Outcomes (1)

• Accuracy of puncture

  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

Study Arms (2)

Group A: Experimental group: Microwave ablation under robot navigation

ACTIVE COMPARATOR

Microwave ablation under robot navigation

Procedure: Robot

Group B: CT-guided microwave ablation

SHAM COMPARATOR

Procedure: CT scan

Interventions

Robot PROCEDURE

Microwave ablation guided by Robot or CT

Group A: Experimental group: Microwave ablation under robot navigation

CT scan PROCEDURE

CT

Group B: CT-guided microwave ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 85 years
• Nodules measuring 3-30mm with ground-glass opacities constituting ≥75% of the lesion
• Preoperative clinical evaluation confirming no hilar or mediastinal lymph node metastasis and no distant metastasis
• 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
• Preoperative ECOG physical status score is 0/1
• ASA score is I-III
• Patients voluntarily participate in this study and sign the informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

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

Central Study Contacts

Shuliang Zhang

CONTACT

+86 15806024509; 670627941@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL