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Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer

NCT06832956 · Guangzhou Medical University · Updated 18 Feb 2025

What is being tested
robotic bronchoscopy system
For
Lung Cancer Patients
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 10 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 15 Feb 2025, ends 31 Dec 2025. Registered 18 Feb 2025.
Results
None posted yet.

In the researchers' words

The goal of this single-arm clinical trial is to evaluate the safety and efficacy of robotic bronchoscopy system (RBS)-assisted cryoablation in the treatment of primary lung cancer in adult patients (aged ≥18 years) with histologically confirmed non-resectable primary lung cancer, regardless of gender. The main questions it aims to answer are: Does RBS-assisted cryoablation achieve a predefined target technical success rate for complete tumor ablation under imaging guidance? Is the incidence of severe procedure-related adverse events within an acceptable safety threshold ? Participants will: Provide written informed consent for RBS-assisted cryoablation. Undergo pretreatment evaluations, including: Multimodal imaging (CT/PET-CT) for tumor localization and staging. Pulmonary function tests and cardiopulmonary risk assessment. Receive RBS-guided cryoablation therapy under general anesthesia. Be monitored for intraoperative complications and postoperative adverse events for 72 hours. Complete follow-up assessments at 1, 3, 6, and 12 months post-procedure, including: Contrast-enhanced CT scans to evaluate local tumor control. Documentation of symptom progression and quality-of-life metrics.
ClinicalTrials.gov, NCT06832956