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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFujian Medical University Union Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Preoperative ECOG physical status score is 0/1

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot

    Procedure/Surgery

    Microwave ablation guided by Robot or CT

  • CT scan

    Procedure/Surgery

    CT

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Group A: Experimental group: Microwave ablation under robot navigationActive comparator 1 intervention
Group B: Group B: CT-guided microwave ablationSham comparator 1 intervention

Trial outcomes

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.

Time frame
24 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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