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NCT Number: NCT07389889

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Robot

Procedure

Microwave ablation guided by Robot or CT

CT Scan

Procedure

CT

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuliang Zhang

CONTACT

[email protected]

+86 15806024509

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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