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Not yet recruiting NCT07389889

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

No phase Interventional Pulmonary Nodules Ground-glass Opacity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot, CT scan.
Who it may be relevant to
Registry conditions: Pulmonary Nodules, Ground-glass Opacity. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Procedure Robot
    Microwave ablation guided by Robot or CT
  • Procedure CT scan
    CT

Primary outcome measures

  • Accuracy of puncture [Time frame: 24 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07389889 · union TC1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗