Not recruiting yet
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.
